503 Biostatistics Jobs

Hello Candidates, We are hiring for the Positions of Project Technical Support III for Agra Location. Post Name :- Project Technical Support III Government Project Number of Vacancy : - 04 Age Limit :- 30 yr Essential Qualifications :- Three Years Graduate degree in relevant subject / field + three Years post qualification experience O r PG in relevant subject / field. Monthly Salary :- 28,000/- + 20% HRA = 33,600/- Per month Name of Project: A study to assess silicosis, tuberculosis and their possible risk factors among glass industry, coal-mines and mica-scavengers silica dust exposed workers: An interventional multi-centric study". And A Case Control Study Assessing the Factors Influencing Disability and Mental Health Among Leprosy Patients Visiting Tertiary Care Facilities in Uttar Pradesh, India" Project Duration:- 12 Months

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Early phase (BABE) statistical data analysis and reporting Statistical protocol inputs and sample size estiamtions Profeciency with regulatory query response and investigations Experience to work with Phoenix WinNonlin & SAS s/w EXPERIENCE Should have work in early phase statistical data analysis & reporting EDUCATIONAL QUALIFICATION M.Sc. (Biostatistics) SAS Programming certifications

Career Category Research Job Description HOW MIGHT YOU DEFY IMAGINATION If you feel like you re part of something bigger, it s because you are. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the world s leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It s time for a career you can be proud of. Join us. Senior Director Biostatistics What you will do Let s do this. Let s change the world. Amgen is expanding its global Biostatistics capabilities, with A mgen India (A IN ) playing a key role in integrated delivery and functional leadership. As Senior Director Biostatistics, you will lead the India-based Biostatistics team; delivering statistical strategy, operational excellence, and digital innovation aligned with our global Clinical Development strategy. This role provides local functional leadership that contributes to global clinical development through seamless execution that leverages digital innovation capabilities . Responsibilities: Lead strategic statistical direction for a portfolio of development programs, aligning with Global Statistical Strategic Plans (GSSPs) and Evidence Generation Plans (EGPs) and influencing global product development decisions. Serve as the primary point of contact for statistical oversight in India; partner with global stakeholders in R&D, regulatory, HEOR, and clinical teams. Oversee operational delivery of statistical activities, ensuring Inspection readiness, data quality, and compliance with regulatory standards. Shape a center of biostatistics excellence at AIN, aligned with Amgen s global standards and operating model, including hiring, onboarding, mentoring, and performance management. Provide governance and oversight of vendor and FSP partnerships, ensuring alignment with performance standards, delivery quality, and operational risk mitigation. Champion the piloting and integration of new technologies , including artificial intelligence, statistical automation tools, and open-source platforms. Contribute to global initiatives in statistical process improvement, digital innovation, and analytics capability building, and represent Amgen s Biostatistics function in scientific and/ or industry forums where applicable. This position is currently located at Amgen India (Hyderabad) . Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a strategic Biostatistics leader with a passion for tech-enabled transformation. Basic Qualifications : Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research with a t least 12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research Master s degree in Statistics/Biostatistics or related subject with high statistical content with at least 15+ years of post-graduate statistical experience in the pharmaceutical industry or medical research Preferred Skills : Doctorate in Statistics/Biostatistics with 12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research Master s degree in Statistics/Biostatistics with 15+ years of Biostatistics experience in the pharmaceutical industry or medical research Experience with global regulatory submissions and HTA/payer collaborations Leadership in building, managing, and mentoring globally distributed teams Proven success in cross-functional stakeholder alignment Strong analytical, problem-solving, and technical communication skills Experience applying or managing AI/ML solutions, including familiarity with R, Python, and automated statistical tools Exposure to cloud platforms or data lakes is a plus Track record of influencing through scientific thought leadership or publications (preferred but not required ) Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being. Vast opportunities to learn and develop within our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits .

Role & responsibilities Responsible for preparation of PK and Statistical Analysis and Statistical reports (BA/BE and Phase 1) for various regulatory submissions. Provide statistical input and sample size calculations during protocol design Provide statistical/programming inputs for CRF design and review Generate randomization lists Prepare statistical analysis plans Perform blinded statistical review to check for data discrepancies Generate statistical analysis data sets Develop programming requirements documents for SAS programmers Perform data analysis and prepare statistical reports Generate data listings, tables and graphs Develop programs for quality control of analysis programs Provide Stat training to SAS programmers and knowledge sharing to statisticians Prepare integrated summaries of efficacy & safety and answer regulatory queries Understand and comply with all SOPs Preparation of appendices in eCTD format. Responsible to respond the sponsor/ regulatory queries Preferred candidate profile The candidate should have minimum 5+yrs experience in BA/BE and Phase-1 studies.

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission -to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. Senior Director Biostatistics What You Will Do Let’s do this. Let’s change the world. Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. As Senior Director Biostatistics, you will lead the India-based Biostatistics team; delivering statistical strategy, operational excellence, and digital innovation aligned with our global Clinical Development strategy. This role provides local functional leadership that contributes to global clinical development through seamless execution that leverages digital innovation capabilities. Responsibilities: Lead strategic statistical direction for a portfolio of development programs, aligning with Global Statistical Strategic Plans (GSSPs) and Evidence Generation Plans (EGPs) and influencing global product development decisions. Serve as the primary point of contact for statistical oversight in India; partner with global stakeholders in R&D, regulatory, HEOR, and clinical teams. Oversee operational delivery of statistical activities, ensuring Inspection readiness, data quality, and compliance with regulatory standards. Shape a center of biostatistics excellence at AIN, aligned with Amgen’s global standards and operating model, including hiring, onboarding, mentoring, and performance management. Provide governance and oversight of vendor and FSP partnerships, ensuring alignment with performance standards, delivery quality, and operational risk mitigation. Champion the piloting and integration of new technologies, including artificial intelligence, statistical automation tools, and open-source platforms. Contribute to global initiatives in statistical process improvement, digital innovation, and analytics capability building, and represent Amgen’s Biostatistics function in scientific and/or industry forums where applicable. This position is currently located at Amgen India (Hyderabad). Win What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a strategic Biostatistics leader with a passion for tech-enabled transformation. Basic Qualifications: Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research with at least 12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research Master’s degree in Statistics/Biostatistics or related subject with high statistical content with at least 15+ years of post-graduate statistical experience in the pharmaceutical industry or medical research Preferred Skills: Doctorate in Statistics/Biostatistics with 12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research Master’s degree in Statistics/Biostatistics with 15+ years of Biostatistics experience in the pharmaceutical industry or medical research Experience with global regulatory submissions and HTA/payer collaborations Leadership in building, managing, and mentoring globally distributed teams Proven success in cross-functional stakeholder alignment Strong analytical, problem-solving, and technical communication skills Experience applying or managing AI/ML solutions, including familiarity with R, Python, and automated statistical tools Exposure to cloud platforms or data lakes is a plus Track record of influencing through scientific thought leadership or publications (preferred but not required) Thrive What You Can Expect Of Us As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Vast opportunities to learn and develop within our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission -to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. Senior Director Biostatistics What you will do Let’s do this. Let’s change the world. Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. As Senior Director Biostatistics, you will lead the India-based Biostatistics team; delivering statistical strategy, operational excellence, and digital innovation aligned with our global Clinical Development strategy. This role provides local functional leadership that contributes to global clinical development through seamless execution that leverages digital innovation capabilities. Responsibilities: Lead strategic statistical direction for a portfolio of development programs, aligning with Global Statistical Strategic Plans (GSSPs) and Evidence Generation Plans (EGPs) and influencing global product development decisions. Serve as the primary point of contact for statistical oversight in India; partner with global stakeholders in R&D, regulatory, HEOR, and clinical teams. Oversee operational delivery of statistical activities, ensuring Inspection readiness, data quality, and compliance with regulatory standards. Shape a center of biostatistics excellence at AIN, aligned with Amgen’s global standards and operating model, including hiring, onboarding, mentoring, and performance management. Provide governance and oversight of vendor and FSP partnerships, ensuring alignment with performance standards, delivery quality, and operational risk mitigation. Champion the piloting and integration of new technologies, including artificial intelligence, statistical automation tools, and open-source platforms. Contribute to global initiatives in statistical process improvement, digital innovation, and analytics capability building, and represent Amgen’s Biostatistics function in scientific and/or industry forums where applicable. This position is currently located at Amgen India (Hyderabad). Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a strategic Biostatistics leader with a passion for tech-enabled transformation. Basic Qualifications: Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research with at least 12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research Master’s degree in Statistics/Biostatistics or related subject with high statistical content with at least 15+ years of post-graduate statistical experience in the pharmaceutical industry or medical research Preferred Skills: Doctorate in Statistics/Biostatistics with 12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research Master’s degree in Statistics/Biostatistics with 15+ years of Biostatistics experience in the pharmaceutical industry or medical research Experience with global regulatory submissions and HTA/payer collaborations Leadership in building, managing, and mentoring globally distributed teams Proven success in cross-functional stakeholder alignment Strong analytical, problem-solving, and technical communication skills Experience applying or managing AI/ML solutions, including familiarity with R, Python, and automated statistical tools Exposure to cloud platforms or data lakes is a plus Track record of influencing through scientific thought leadership or publications (preferred but not required) Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Vast opportunities to learn and develop within our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. Senior Director Global Statistical Programming What You Will Do Let’s do this. Let’s change the world. Amgen is expanding its global Statistical Programming capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As Sr. Director of Statistical Programming, you will provide local functional leadership from AIN, supporting global clinical development programs in close partnership with global teams through seamless execution that leverages digital innovation to drive quality deliverables, operational excellence, and regulatory compliance. Responsibilities: Provide strategic and operational leadership for statistical programming delivery within Amgen’s global framework, with site accountability based in AIN. Oversee the execution of statistical programming activities in AIN, ensuring quality, timeliness, compliance, and inspection readiness. Shape and grow a center of programming excellence at AIN, aligned with Amgen’s global delivery model and standards, including hiring, onboarding, mentoring, and performance management. Lead the implementation of reusable code frameworks, standardized processes, and scalable programming models to drive quality, speed, and consistency. Collaborate cross-functionally with Biostatistics, Data Management, and Regulatory Writing to align programming deliverables with strategic timelines. Champion the piloting and integration of new technologies, including artificial intelligence, statistical programming automation tools, and open-source platforms to improve quality and efficiency. Contribute to global initiatives in statistical process improvement, digital innovation, and analytics capability building. This position will be located at Amgen India (Hyderabad). Win What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation. Basic Qualifications: BA/BSc or higher degree in biostatistics, statistics, mathematics, or other related quantitative or scientific subjects Preferred Skills: MSc or higher degree in biostatistics, statistics, mathematics, or related quantitative or scientific subjects Extensive experience with SAS and CDISC standards, and with global regulatory submissions Demonstrated success managing large teams to complete end to end statistical programming activities from study start up to regulatory submissions Familiarity with open-source programming tools (e.g. R, Python), automation platforms, and emerging technologies in statistical programming Experience applying or managing Agentic AI or automated workflows within a GxP environment Proven ability to drive process innovation, implement standardization strategies, and deliver high-quality outputs across studies Strong cross-functional collaboration skills and ability to work in a global matrix structure Excellent communication and leadership skills, with the ability to influence at multiple levels of the organization Thrive What You Can Expect Of Us As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

We are Hiring for Clinical Research Trainer (Offline) Title: Clinical Research Trainer (Offline) Location: Jayanagar Mode: Offline (On-site) Department: Training & Development Job Purpose To design, deliver, and evaluate high-quality training programs in Clinical Research, ensuring that students/professionals gain practical knowledge and industry-ready skills aligned with current regulatory standards and practices. Key Responsibilities : Deliver offline classroom training sessions on Clinical Research topics such as: Drug Development Process Good Clinical Practice (GCP) & ICH Guidelines Clinical Trial Phases & Protocols Regulatory Requirements (USFDA, EMA, CDSCO, etc.) Pharmacovigilance, Medical Writing, Data Management & Biostatistics basics Develop training materials, case studies, and assessments to enhance learning outcomes. Mentor and guide students/professionals on industry practices and career opportunities. Conduct interactive workshops, mock interviews, and soft skills sessions. Evaluate trainees’ performance through assignments, assessments, and feedback sessions. Stay updated with latest industry trends, guidelines, and technological tools in Clinical Research. Coordinate with placement teams to prepare trainees for job readiness. Maintain training records, reports, and feedback documentation. Qualifications & Skills Education: Master’s degree in Life Sciences/Pharmacy/Clinical Research/Medical Sciences (M.Sc., M.Pharm, MBBS, MD, etc.). Experience: Minimum 2–5 years of experience in Clinical Research/Clinical Operations/Pharmacovigilance/Data Management. Prior teaching/training experience preferred. Skills: Strong knowledge of ICH-GCP and regulatory guidelines. Excellent presentation, communication, and mentoring skills. Ability to engage and motivate trainees. Proficiency in MS Office and training tools. Why Join Us? Opportunity to shape the next generation of Clinical Research professionals. Exposure to diverse training modules and real-time case studies. Collaborative and growth-oriented environment. Interested ones please share your resume to hr@clinogenesis.com

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Director - Biostatistics, Lilly Bengaluru At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. Lilly capability center India is an important part of Lilly’s strategy of leveraging and integrating global talent towards delivering timely medicines to patients in need. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose Eli Lilly and Company, Global Statistical Sciences (GSS) has established statistical capabilities in LCCI, India to support the global function. GSS is responsible for providing statistical expertise in the domains of study design, data analysis methods, results interpretation, learning/applying new methods, and improving existing methods. Members of the GSS organization partner regularly with others (scientists, physicians, marketing, etc.) to improve drug discovery, development, and commercialization. The Director - Biostatistics, LCCI is accountable for providing strategic and operational leadership for GSS at Bangalore and will be responsible for working with GSS leadership in developing, managing, and implementing global strategies and tactical direction for statistical deliverables across the Lilly portfolio in a more productive, effective way. This role will oversee a flexible, efficient organization that can respond to changes in the pipeline and continue to deliver on evolving business demands and external trends. To accomplish this, it is necessary for the Senior Director to excel in high quality operational excellence, problem-solving, leadership behaviors across the teams to create a highly engaged motivated workforce and deliver results. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Enabling GSS Deliverables Provide strategic direction and oversight for GSS at LCCI Be a leader both within GSS and across R&D, contributing to cross-functional initiatives and influencing the field as applicable Partner closely with GSS and local Associate VP/VPs to effectively plan, forecast, and manage the resources required to deliver all projects Drive efficiency and continuous improvement within LCCI and across GSS to support therapeutic area and Business Unit aligned deliverables Statistical And Analytical Capabilities Development Establish deep technical capabilities at LCCI with supervision of direct reports and a total staff comprised of diverse skill set accountable for hands-on statistical activities Develop strategies and build capabilities and expertise within the team catering to advanced statistical capabilities Build-up, maintain and foster deep therapeutic, scientific excellence and environmental expertise to ensure accountability and proactive ability to deliver specific business needs Facilitate appropriate staff interactions with academic and professional external organizations Use national and international network of experts to address specific scientific questions across phases; leveraging and supporting the global stats network in order to speed innovation Site Leadership and Partnership Drive strong partnership and engage with Site Leadership, LRL at LCCI and other functional groups to support site strategy and effectiveness Partner closely with the GSS team at Cork as well as the GSS leadership at the Lilly Corporate Center to drive efficiency, continuous improvement, and investigate opportunity at all site(s) Enterprise Leadership Within functional and cross-functional teams, exhibit strong business acumen, strong problem-solving skills and agility to adjust to changing business priorities and needs Maintain awareness of external environment through benchmarking, external collaborations, contacts and professional organization involvement, and represent GSS at appropriate internal and external venues Accountable for fiscal responsibility of GSS at LCCI Ensure that activities are performed according to established guidelines, best practices, and in compliance with all laws and regulations Drive continuous improvement of key performance metrics Drive shared learning and process expertise between teams within the organization People Management and Development Provide leadership and development for direct reports Recruit, develop, and retain a strategic and operationally capable workforce skilled and knowledgeable in statistical methods and analytical thinking Effectively create and manage an agile organization that continuously meets the needs of a changing portfolio Build an organizational culture that fosters inclusion and innovation. Create an environment that fosters professional and career development. In partnership with line management, develop the team’s expertise in drug development, therapeutic area science, strategic thinking, project management and leadership Minimum Qualification Requirements Ph.D. in Statistics/Biostatistics Minimum of 15 years of industry experience 7 years of supervisory experience; 5 years as a leader of leaders preferred Broad knowledge of the drug development process which includes industry requirements, quality expectations, and practices. Ability to develop and implement strategies across people, processes, organizations and technology. Ability to partner and influence across matrixed organization and collaborate with peers locally and globally Ability to communicate clearly and succinctly with all audiences and forums through strong oral and written communication Proactively identifies issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Demonstrated success in leading teams effectively Other Information/Additional Preferences Minimum travel expected (10%) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Associate Director – Statistics, Lilly Bengaluru At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. Lilly capability center India is an important part of Lilly’s strategy of leveraging and integrating global talent towards delivering timely medicines to patients in need. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose: The purpose of the Associate Director – Statistics role is to define, staff and lead a statistical science function to provide administrative direction, leadership, process expertise and influence to members of the broader Statistics, Data & Analytics organization. The Associate Director is primarily responsible for on-time and high quality Portfolio deliverables, appropriate staffing, budget and resource management, asset protection, coaching and mentoring, staff development, performance management, project planning/management, knowledge sharing, regulatory compliance, strategy implementation and execution, and process improvements. The Associate Director will also be accountable for developing the statistical capabilities at LILLY, BENGALURU supporting and or leading implementation of next generation drug development and advanced analytics. This leader will contribute to establishing a long-term competitive advantage with the function by recruiting and developing the top talent, integrating the LILLY, BENGALURU team and increasing the effectiveness and efficiency of the LILLY, BENGALURU statistics team. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Portfolio Delivery & Strategy Develop comprehensive understanding of the Lilly’s Therapeutic areas, Establish and lead a cross-functional team, be a scientific thought leader for the group to enable effective and efficient delivery of high-quality clinical outcomes with aggressive metrics. Effectively and efficiently deliver the business unit portfolio with quality, on-time Participate in strategy development and monitor metrics for on-time delivery of statistical support Assess demand for resources, prioritize work, and resolve issues related to scope of work Coordinate resource allocation and tracking for internal and outsourced projects Communicate and resolve issues related to statistics with appropriate level of customer team personnel Partner with Global leaders in driving project decisions related to clinical data execution options Partner closely with other development and administrative functions to effectively plan, forecast, and manage the resources required to deliver all sanctioned projects Develop deep therapeutic area expertise within LILLY, BENGALURU teams Statistical And Analytical Capabilities Development Establish deep technical capabilities at LILLY, BENGALURU with supervision of direct reports and a total staff comprised of diverse skill set accountable for hands-on statistical activities Develop strategies and build, capabilities and expertise within the team catering to advanced statistical capabilities Build-up, maintain and foster deep therapeutic, scientific excellence and environmental expertise to ensure accountability and proactive ability to deliver specific business needs Enterprise Leadership Within functional and cross-functional teams, exhibit strong technical know-how, business acumen, strong problem-solving skills and agility to adjust to changing business priorities and needs Represent the Statistics, Data & Analytics organization at appropriate internal and external venues to demonstrate the leadership Maintain awareness of regulatory requirements, particularly those related to the US, EU, Japan, and China, and be connected externally to be considered an external thought leader Be influential as an external thought leader in the area of statistics by being highly connected and driving changes at the industry level Ensure that activities are performed according to established guidelines, best practices, and in compliance with all laws and regulations Drive continuous improvement of key performance metrics Drive shared learning and process expertise between teams within the organization People Management and Development Provide technical leadership in developing future statistics leaders Provide leadership in recruiting, coaching and mentoring LILLY, BENGALURU talent and integrating them into global teams Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in Statistics, Data & Analytics Effectively create and manage an agile organization that continuously meets the needs of a changing portfolio Build an organizational culture that fosters inclusion and innovation. Develop staff who demonstrate expertise in drug development, therapeutic area science, project management and cross-functional leadership Develop an organizational talent base that demonstrates judgment-based decision making, and provides leadership in clinical delivery Minimum Qualification Requirements M.S. or Ph.D. in Statistics/Biostatistics Minimum of 10 years of industry experience Broad knowledge of the drug development process which includes industry requirements, quality expectations, and practices. Other Information/Additional Preferences Demonstrated management and leadership capabilities both with internal staff and outside partners Strong project management skills Exceptional team building and relationship building skills Demonstrated ability to influence across boundaries Demonstrated ability to think and operate creatively and strategically Strong communication skills Strong computational capability. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly

Overview: The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to the mission of saving lives and reducing the burden of disease in low-and middle-income countries. We work at the invitation of governments to support them and the private sector to create and sustain high-quality health systems. CHAI was founded in 2002 in response to the HIV/AIDS epidemic with the goal of dramatically reducing the price of life-saving drugs and increasing access to these medicines in the countries with the highest burden of the disease. Over the following two decades, CHAI has expanded its focus. Today, along with HIV, we work in conjunction with our partners to prevent and treat infectious diseases such as COVID-19, malaria, tuberculosis, and hepatitis. Our work has also expanded into cancer, diabetes, hypertension, and other non-communicable diseases, and we work to accelerate the rollout of lifesaving vaccines, reduce maternal and child mortality, combat chronic malnutrition, and increase access to assistive technology. We are investing in horizontal approaches to strengthen health systems through programs in human resources for health, digital health, and health financing. With each new and innovative program, our strategy is grounded in maximizing sustainable impact at scale, ensuring that governments lead the solutions, that programs are designed to scale nationally, and learnings are shared globally. At CHAI, our people are our greatest asset, and none of this work would be possible without their talent, time, dedication and passion for our mission and values. We are a highly diverse team of enthusiastic individuals across 40 countries with a broad range of skillsets and life experiences. CHAI is deeply grounded in the countries we work in, with majority of our staff based in programming countries. In India, CHAI works in partnership with its India registered affiliate William J Clinton Foundation (WJCF) under the guidance of the Ministry of Health and Family Welfare (MoHFW) at the Central and States' levels on an array of high priority initiatives aimed at improving health outcomes. Currently, WJCF supports government partners across projects to expand access to quality care and treatment for HIV/AIDS, Hepatitis, tuberculosis, COVID-19, common cancers, sexual and reproductive health, immunization, and essential medicines. Learn more about our exciting work: http://www.clintonhealthaccess.org Program Overview: India continues to bear the world’s highest burden of tuberculosis (TB) in terms of absolute numbers of incident TB cases. National TB prevalence survey (2019-21) revealed a significant 31.3% (estimated) crude prevalence of TB infection (TBI) among India’s population aged 15 years and above. Moreover, India has set an ambitious target of eliminating TB by 2025. The National Strategic Plan 2017–2025 outlines a critical target of initiating 95% of identified/eligible TBI cases on TB Preventive Treatment (TPT) by 2025. The TB Household Contact Management (TB HCM) project is a pioneering initiative addressing critical gaps in coverage and completion of TPT amongst household contacts of notified drug sensitive pulmonary TB patients, with particular focus on under five (U5) children. Planned to be implemented in Bihar and Uttar Pradesh, this four-year TB HCM project aims to impact over 2.5 million individuals through a community-based service delivery model that leverages community health workers from the National Tuberculosis Elimination Programme (NTEP) and general health systems. As the first large-scale implementation of TPT while focusing on Universal Health Coverage strategies, the project focuses on decentralizing and strengthening TB care within general health systems. Additionally, it incorporates an impact evaluation component, further enhancing its significance in advancing TB prevention and care in alignment with national health priorities and international best practices. Position Summary: WJCF seeks a highly motivated, results-oriented Senior Research Associate to support the TB HCM project, reporting to the National Monitoring, Evaluation & Research Manager. The role involves supporting study implementation, coordinating evaluation activities, providing technical input, and contributing to evidence generation to advance TB prevention strategies. The ideal candidate is a strategic thinker with strong leadership, analytical, and problem-solving skills, capable of working independently and collaboratively in a fast-paced, multicultural environment with appropriate guidance and mentorship. The Senior Research Associate will support engagement with government counterparts, donors, and external partners, and work across WJCF/CHAI teams to ensure project success. Responsibilities: 1. Coordination of external evaluation activities –40% Support and coordinate communication with the evaluation agency, ensuring alignment between the evaluation and program implementation, with the objective of ensuring timely information flow regarding any risks to the core elements of the program Support fieldwork for the planned RCT embedded within the program, ensuring high-quality data collection training. The candidate will also be expected to establish quality control mechanisms, implement them, and provide regular updates to the core national and global teams. Proactively identify and address any challenges affecting the design and implementation of the evaluation. Serve as the primary day-to-day point of contact for the evaluation agency, managing ongoing coordination activities not explicitly listed above, and ensuring the evaluation and implementation processes remain aligned under the guidance of the senior team. 2. Technical review and input – 25% Contribute to the technical review of study protocols, instruments, evaluation design, and analysis plans, in collaboration with the broader technical team Support the design, refinement, and implementation of an embedded randomized controlled trial (RCT) and other qualitative components (e.g., process evaluations, qualitative interviews) to assess the impact of the CbHCM model Assist with the submission of study tools to the Institutional Review Board (IRB) and other relevant Indian authorities (such as HMSC), as required Where needed, analyze quantitative data using Stata or other statistical software. Additionally, they contribute to the design of qualitative tools and assist in their implementation and analysis, including transcript coding using appropriate qualitative analysis software Collaborate with the technical team to respond to donor inquiries related to the impact evaluation and/or data from routine program monitoring 3. Evidence generation & Synthesis of learning – 35% Conduct primary and secondary research to address learning and evidence gaps in strategically relevant areas of implementation and evaluation. Support the in-country learning agenda by identifying and addressing evidence gaps for NTEP and CHAI/WJCF through complementary analyses. Participate in systematic reviews of secondary literature on related themes and maintain a bibliography of key citations using reference management software Work closely with the National Monitoring & Evaluation Manager to align evaluation and program monitoring workstreams. Contribute to synthesizing learnings from implementation and evaluation efforts to inform new ideas and guide intervention design Support the development and delivery of learning and dissemination materials, including reports, manuscripts, and other documentation Qualifications: Bachelor’s or Master’s in epidemiology, economics, biostatistics, or a related field with significant focus on quantitative skills (e.g., epidemiology and public/global health) with a strong understanding of inferential statistics). Minimum 5 years of applied work experience in resource-limited settings and/or a field requiring analytical problem-solving. Technical Skills: Strong command of experimental, quasi-experimental study designs and qualitative research methods Experience in designing and implementing quantitative models and/or impact evaluation and/or qualitative research; fluency in concepts of statistical inference and data analysis Strong skills in quantitative modeling, data management, and statistical analysis using software like Stata/R Demonstrated experience with data collection workflows and platforms, such as SurveyCTO, Google sheets or similar tools Demonstrated experience with or involvement in the implementation of RCTs/Or quasi experimental or similar studies in India Experience piloting survey instruments, training data collectors, and leading field logistics for large-scale studies Stakeholder management and communication: An ability to communicate complex concepts clearly and support the development of actionable recommendations for a range of audiences including Ministries of Health, global donors and policy makers Strong interpersonal skills, and an ability to navigate multi-cultural, multi-stakeholder situations collaboratively to achieve intended results Organization, time management and self-motivation: Exceptional organizational skills and ability to approach complex problems in a structured manner Strong ability to work independently, to develop and execute work-plans, and to achieve specified goals with limited guidance and oversight in a fast-paced environment Demonstrated capacity to thrive in a work environment that requires effective balancing across parallel workstreams and deliverables Willingness to travel (at least 25%) to Bihar and Uttar Pradesh Last Date to Apply: 29th September, 2025

Description Medical Writer II Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities 1 to 3 years of experience in Disclosure. Knowledge of Clinical Research, Clinical Trial , clinical registries (CT.gov, CTIS- Clinical Trial information System , EUDRACT). Experience in clinical registries, clinical trial Disclosure is mandatory Fine with candidate with combination of redaction Disclosure. Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables Perform online clinical literature searches and comply with copyright requirements Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentor and lead less experienced medical writers on complex projects Develop deep expertise on key topics in the industry and regulatory requirements Work within budget specifications for assigned projects. Qualifications: Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred. Client interaction experience. Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required Experience writing relevant document types required Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style Necessary Skills: Strong presentation, proofreading, collaborative, and interpersonal skills Strong project and time management skills Strong proficiency in MS Office Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Description Medical Writer I (CTD/CTT) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities JOB RESPONSIBILITIES Candidate with min 6 months - 1year of experience of clinical Trial Disclosure or CTT Should have good experience protocol registration, result registration Should have excellent communication and client mgt experience. Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision. Develops or supports, a variety of documents that include but not limited to: Clinical study protocols and clinical study protocol amendments; Clinical study reports; Patient narratives; Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills. Is aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Job Description Summary JOB SUMMARY Serves as medical writer on clinical study or regulatory project teams. Assists in writing, editing, and coordinating content for clinical/regulatory documents with dependent staff roles to ensure satisfactory completion of all writing projects.

The ideal candidate for this role in Hyderabad should have a minimum of 12 years of experience in the Life Science / Pharma domain, particularly in Clinical development portfolio. This includes expertise in Clinical Data Services from Data Source to Regulatory Submission, covering areas such as Clinical Data Management, Biostatistics, Statistical Programming, and Medical writing. As a key team member, you will be responsible for both new customer acquisition and growing existing customer accounts. Your focus will be on creating a healthy opportunity pipeline to meet business goals related to new Headcount acquisition and Revenue. Developing strong relationships across different buyers in the organization will be crucial for success in this role. To stay ahead of the curve, you will need to continuously analyze the latest market trends, including the competitive landscape. Experience working in markets such as India, USA, UK, and EU will be highly valued. In addition, you should be able to forecast monthly and quarterly sales targets and demonstrate a track record of successfully executing them within the given time frame. Your ability to effectively manage internal stakeholders to meet customer expectations will be a key factor in achieving overall success in this position.,

The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to the mission of saving lives and reducing the burden of disease in low-and middle-income countries. We work at the invitation of governments to support them and the private sector to create and sustain high-quality health systems. CHAI was founded in 2002 in response to the HIV/AIDS epidemic with the goal of dramatically reducing the price of life-saving drugs and increasing access to these medicines in the countries with the highest burden of the disease. Over the following two decades, CHAI has expanded its focus. Today, along with HIV, we work in conjunction with our partners to prevent and treat infectious diseases such as COVID-19, malaria, tuberculosis, and hepatitis. Our work has also expanded into cancer, diabetes, hypertension, and other non-communicable diseases, and we work to accelerate the rollout of lifesaving vaccines, reduce maternal and child mortality, combat chronic malnutrition, and increase access to assistive technology. We are investing in horizontal approaches to strengthen health systems through programs in human resources for health, digital health, and health financing. With each new and innovative program, our strategy is grounded in maximizing sustainable impact at scale, ensuring that governments lead the solutions, that programs are designed to scale nationally, and learnings are shared globally. At CHAI, our people are our greatest asset, and none of this work would be possible without their talent, time, dedication and passion for our mission and values. We are a highly diverse team of enthusiastic individuals across 40 countries with a broad range of skillsets and life experiences. CHAI is deeply grounded in the countries we work in, with majority of our staff based in programming countries. In India, CHAI works in partnership with its India registered affiliate William J Clinton Foundation (WJCF) under the guidance of the Ministry of Health and Family Welfare (MoHFW) at the Central and States' levels on an array of high priority initiatives aimed at improving health outcomes. Currently, WJCF supports government partners across projects to expand access to quality care and treatment for HIV/AIDS, Hepatitis, tuberculosis, COVID-19, common cancers, sexual and reproductive health, immunization, and essential medicines. Learn more about our exciting work http//www.clintonhealthaccess.org Program Overview India continues to bear the world’s highest burden of tuberculosis (TB) in terms of absolute numbers of incident TB cases. National TB prevalence survey (2019-21) revealed a significant 31.3% (estimated) crude prevalence of TB infection (TBI) among India’s population aged 15 years and above. Moreover, India has set an ambitious target of eliminating TB by 2025. The National Strategic Plan 2017-2025 outlines a critical target of initiating 95% of identified/eligible TBI cases on TB Preventive Treatment (TPT) by 2025. The TB Household Contact Management (TB HCM) project is a pioneering initiative addressing critical gaps in coverage and completion of TPT amongst household contacts of notified drug sensitive pulmonary TB patients, with particular focus on under five (U5) children. Planned to be implemented in Bihar and Uttar Pradesh, this four-year TB HCM project aims to impact over 2.5 million individuals through a community-based service delivery model that leverages community health workers from the National Tuberculosis Elimination Programme (NTEP) and general health systems. As the first large-scale implementation of TPT while focusing on Universal Health Coverage strategies, the project focuses on decentralizing and strengthening TB care within general health systems. Additionally, it incorporates an impact evaluation component, further enhancing its significance in advancing TB prevention and care in alignment with national health priorities and international best practices. Position Summary WJCF seeks a highly motivated, results-oriented Senior Research Associate to support the TB HCM project, reporting to the National Monitoring, Evaluation & Research Manager. The role involves supporting study implementation, coordinating evaluation activities, providing technical input, and contributing to evidence generation to advance TB prevention strategies. The ideal candidate is a strategic thinker with strong leadership, analytical, and problem-solving skills, capable of working independently and collaboratively in a fast-paced, multicultural environment with appropriate guidance and mentorship. The Senior Research Associate will support engagement with government counterparts, donors, and external partners, and work across WJCF/CHAI teams to ensure project success. Coordination of external evaluation activities -40% Support and coordinate communication with the evaluation agency, ensuring alignment between the evaluation and program implementation, with the objective of ensuring timely information flow regarding any risks to the core elements of the program Support fieldwork for the planned RCT embedded within the program, ensuring high-quality data collection training. The candidate will also be expected to establish quality control mechanisms, implement them, and provide regular updates to the core national and global teams. Proactively identify and address any challenges affecting the design and implementation of the evaluation. Serve as the primary day-to-day point of contact for the evaluation agency, managing ongoing coordination activities not explicitly listed above, and ensuring the evaluation and implementation processes remain aligned under the guidance of the senior team. Technical review and input - 25% Contribute to the technical review of study protocols, instruments, evaluation design, and analysis plans, in collaboration with the broader technical team Support the design, refinement, and implementation of an embedded randomized controlled trial (RCT) and other qualitative components (e.g., process evaluations, qualitative interviews) to assess the impact of the CbHCM model Assist with the submission of study tools to the Institutional Review Board (IRB) and other relevant Indian authorities (such as HMSC), as required Where needed, analyze quantitative data using Stata or other statistical software. Additionally, they contribute to the design of qualitative tools and assist in their implementation and analysis, including transcript coding using appropriate qualitative analysis software Collaborate with the technical team to respond to donor inquiries related to the impact evaluation and/or data from routine program monitoring Evidence generation & Synthesis of learning - 35% Conduct primary and secondary research to address learning and evidence gaps in strategically relevant areas of implementation and evaluation. Support the in-country learning agenda by identifying and addressing evidence gaps for NTEP and CHAI/WJCF through complementary analyses. Participate in systematic reviews of secondary literature on related themes and maintain a bibliography of key citations using reference management software Work closely with the National Monitoring & Evaluation Manager to align evaluation and program monitoring workstreams. Contribute to synthesizing learnings from implementation and evaluation efforts to inform new ideas and guide intervention design Support the development and delivery of learning and dissemination materials, including reports, manuscripts, and other documentation Bachelor’s or Master’s in epidemiology, economics, biostatistics, or a related field with significant focus on quantitative skills (e.g., epidemiology and public/global health) with a strong understanding of inferential statistics). Minimum 5 years of applied work experience in resource-limited settings and/or a field requiring analytical problem-solving. Technical Skills Strong command of experimental, quasi-experimental study designs and qualitative research methods Experience in designing and implementing quantitative models and/or impact evaluation and/or qualitative research; fluency in concepts of statistical inference and data analysis Strong skills in quantitative modeling, data management, and statistical analysis using software like Stata/R Demonstrated experience with data collection workflows and platforms, such as SurveyCTO, Google sheets or similar tools Demonstrated experience with or involvement in the implementation of RCTs/Or quasi experimental or similar studies in India Experience piloting survey instruments, training data collectors, and leading field logistics for large-scale studies Stakeholder management and communication An ability to communicate complex concepts clearly and support the development of actionable recommendations for a range of audiences including Ministries of Health, global donors and policy makers Strong interpersonal skills, and an ability to navigate multi-cultural, multi-stakeholder situations collaboratively to achieve intended results Organization, time management and self-motivation Exceptional organizational skills and ability to approach complex problems in a structured manner Strong ability to work independently, to develop and execute work-plans, and to achieve specified goals with limited guidance and oversight in a fast-paced environment Demonstrated capacity to thrive in a work environment that requires effective balancing across parallel workstreams and deliverables Willingness to travel (at least 25%) to Bihar and Uttar Pradesh Last Date to Apply 29th September, 2025

Work Schedule Other Environmental Conditions Office At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Summarized Purpose: We are excited to be expanding our Medical Writing FSP Team in India. We seeking a PMW dedicated to a client in the FSP space; preferred candidates will have experience in Structured Content Authoring systems and automation to support delivery. The ideal candidate will be experienced and highly skilled, responsible for creating, reviewing, and managing clinical regulatory documents. This role requires a strong understanding of scientific concepts, exceptional writing skills, and the ability to communicate complex information clearly and concisely. Key Responsibilities: Lead the development, writing, and editing of complex clinical and regulatory documents. Collaborate with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and medical affairs, to ensure the accurate and timely completion of documents. Ensure documents align with regulatory guidelines, company standards, and industry best practices. Provide strategic input and guidance on document content, structure, and presentation. Mentor and provide oversight to junior medical writers and ensure high-quality deliverables. Manage multiple writing projects simultaneously and prioritize tasks effectively. Stay current with industry trends, guidelines, and regulatory requirements. Education and Experience: Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred. Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role (comparable to 8+ years in core Regulatory Medical Writer role capacity). Experience working in the pharmaceutical/CRO industry required. Experience in managing and directing complex medical writing projects required. Extensive experience in Phase 3 CSRs and/or protocol development required. EU CTR experience preferred. Experience working on structured content management system and AI-driven content creation, and familiarity with Natural Language Generation preferred. Knowledge, Skills, and Abilities: Excellent organizational and program management skills. Proven leadership skills to manage and mentor a team of medical writers. Extensive knowledge of regulatory guidelines and drug development processes. Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders. Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards. Self-motivated and adaptable. Excellent judgment; high degree of independence in decision making and problem solving. Capable of mentoring and leading junior level staff. What We Offer: At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a Biostatistician Technical Expert - Clinical Statistics within our Clinical Statistics Team at Hyderabad, you’ll lead/oversee statistical support of a team of senior and principal biostatisticians, be accountable for statistical aspects and deliverables of the team for several early/late phase studies. Provide directions and guidance in carrying out project assignments, interacting with other internal functions and applying advanced statistical methods while ensuring scientific integrity to project work. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main responsibilities: Support the clinical development plan (CDP), clinical study design (including protocol development and review), the study setup and conduct. Conduct / Oversee the execution of the statistical analyses according to the SAP and ISAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs. Serve as a biostatistical consultant for other members of the department and staff members from other statistics department within the organization. Provide mentoring and coaching advanced statistical methodologies to junior statisticians in Hub. Maintain knowledge and awareness of development in biostatistics and clinical trial methodology and regulatory requirements that impact on analysis. Accountable for all assigned statistical deliverables related to multiple studies or specific domains: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, Estimands etc., SAP, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables). Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives. Contribute to define and review the specific deliverables related to Transparency and Disclosure. Coordinate with study programmer the production and Qc of statistical analyses. Contribute to operation process optimization and provide inputs to statistics and quality standards. Represent statistics team to participate in scientific or technology working groups or cross function initiatives. undefined About you Write 3 to 7 bullet points describing the essential criteria. Long lists can deter people from underrepresented groups, so stick to the real must-haves for a more diverse pool. Criteria worth covering include: Experience : 7+ years (MS) or 5+ years (PhD) of solid pharmaceutical industry experiences. Experience of project management and development preferred. Soft and technical skills : Broad knowledge and good understanding of advanced statistical concepts and techniques Demonstrated strong project/study management, interpersonal and communication skills. Good knowledge of pharmaceutical clinical development, together with early, late phase and post-marketing experiences Extensive ability to apply advanced statistical analyses using SAS and R languages. Knowledge or experience with Artificial intelligence or Generative AI is a plus Education : MS or PhD degree in Statistics or relevant fields Languages : Highly effective communication in English, both oral and written. null

Principal Clinical Programmer (RAVE EDC) Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Lead in the evaluation, implementation, and validation of packaged systems. Create, maintain, and oversee processes for providing end user support in EDC systems. Build studies and support other users to build studies in EDC and other GxP systems. Works as part of a project team to design and implement clinical database applications in support of clinical research and biostatistics analysis. Processes database programming change requests. Documents all work fully according to FDA regulations and guidances, and company SOPs. Actively promotes standards for the development and acquisition of, and serve as the SME for, GxP systems. Mentors/trains junior level clinical programmers. Primary Responsibilities Lead the development, validation, and maintenance of clinical databases for clinical trials using a variety of validated software applications Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management plans Develop and maintain global library of clinical database forms, edit checks, and other regularly used programs and routines Implement and test data quality checks in accordance with the study data validation manual Manage and develop programs for the reconciliation of external data from vendors (e.g., central lab data) Serves as SME and facilitates integration of EDC systems to other clinical platforms such as CTMS, Reporting, IRT as needed Assist in managing and updating medical coding dictionaries, including but not limited to MedDRA and WHODrug Oversee the management of EDC, other GxP system user accounts and other help desk activities Track issues in EDC systems, work with EDC vendors to resolve, and escalate issues appropriately to senior management. Quickly learn new and/or advancements in software to become the SME for any technical question Demonstrate good problem-solving skills, a proactive approach, and a willingness to make decisions, seeking advice when necessary Facilitate and/or participate in writing departmental documentation (e.g., training documents, process guidance) Exhibit good time management and organization skills; the ability to work in an efficient manner and prioritize tasks to meet tight deadlines while maintaining the highest standards of work Keep management team abreast of issues, progress, and risks related to trial operations Support bid defenses from a technical SME perspective Participate in other clinical programming and data management activities, as required Participate in internal and external team meetings, as required Mentor junior level clinical programmers Adhere to all aspects of the Statistics & Data Corporation’s quality system Comply with Statistics & Data Corporation’s data integrity & business ethics requirements Perform other related duties incidental to the work described herein The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Requirements Required Skills At least eight years’ experience assuming lead database programming responsibilities on projects, with a minimum of 5 years in a clinical environment Excellent understanding of relational database structures Fast, accurate programming skills using assorted application software PL/SQL, SQL, and XML programming skills Solid interpersonal skills, with the ability to work well with people of all levels of expertise and comfort in varied organizational relationships Demonstrated ability to provide both “user-friendly” and technical documentation Ability to provide expertise to guide department in continued efficiency and growth Knowledge and experience with FDA regulations and guidances (e.g., 21 CFR Part 11, ICH/GCP) Knowledge of installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment C#, C++, .NET, Visual Basic or other object-oriented language, and/or SAS programming knowledge / experience not required, but desirable Medidata Rave and iMedNet EDC knowledge / experience not required, but desirable Reporting application development (e.g., JReview, Business Objects, PowerBI) knowledge / experience not required, but desirable Education or Equivalent Experience Bachelor’s degree in computer science or other quantitative or scientific discipline with 8+ years’ experience in database programming and demonstrated working knowledge of scientific principles. Commensurate experience with clinical database programming and database administration will be considered as an alternative to a degree Benefits Why SDC SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry. We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! #LI-Hybrid

Role & responsibilities Collaborate with clinical and research teams to design clinical trials, including statistical analysis plans and sample size calculations. Perform statistical analyses of clinical trial data using appropriate statistical methods and software. Prepare statistical reports, summaries, and contribute to the writing of regulatory submissions, manuscripts, and presentations. Ensure the accuracy and integrity of data through comprehensive reviews and validation of datasets. Provide guidance to CDM in preparation of CRF designing and identification of critical data points and data validation. Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables. Preferred candidate profile Demonstrate strong written and verbal communication skills.

Summary Position Summary Job Description - Strategy & Transactions – Strategy (Consultant) At Deloitte Strategy & Transactions (S&T), we don’t just advise — we architect the future. Our team is uniquely positioned at the intersection of strategy and execution, empowering clients to tackle their most pressing challenges and unlock transformative growth. We work with C-suite executives, Boards, and business leaders to answer the questions that matter most — from navigating complex M&A and driving digital transformation, to reshaping operating models and unlocking new market opportunities. We are trusted advisors during our clients' most critical, high-stakes moments. But we don’t stop at client impact — we are equally passionate about investing in our people. At S&T, you’ll be part of a dynamic team culture that accelerates leadership development, fosters curiosity, and delivers hands-on experience at the forefront of strategy and transactions. We design differentiated career paths that empower our talent to thrive. Our capabilities span the full lifecycle of transformation — from Enterprise and Growth Strategy to Enterprise Technology and Transformation Strategy , end-to-end M&A, valuation and modeling, and performance improvement & restructuring, to infrastructure & real estate advisory and sustainability-driven innovation. If you’re looking to work where bold thinking meets real-world impact — and where your growth matters as much as your clients’ — Strategy & Transactions is your next move. The team Our Strategy practice brings together several key capabilities that will allow us to architect integrated programs that transform our clients’ businesses, including Corporate & Business Unit Strategy, Technology Strategy & Insights, Enterprise Model Design, Enterprise Cloud Strategy and Business Transformation. Strategy professionals will serve as trusted advisors to our clients, working with them to make clear data-driven choices about where to play and how to win, in order to drive growth and enterprise value. Work you will do: Deloitte’s ‘Strategy’ offering helps companies address the entire range of top management challenges including pursuing new growth opportunities, developing go-to-market strategies, channel strategies, and pricing strategies. Identify strategies for growth and value creation Develop the appropriate business models, technology operating models, and capabilities to support their strategic vision Maximize the ROI on technology investments and leverage technology trends to architect future technology strategies Required Experience And Skills Enterprise Technology and Transformation Strategy – Life Sciences and Health Care (LSHC) LSHC Industry Experience Consulting experience for clients in the Life Sciences and Healthcare industry Hands-on exposure of working for / with leading companies in the Life Sciences (Pharmaceutical / Biotech), US Provider and/or US Payor/Health Plan/PBM industries (minimum 1+ year of experience) Awareness of industry trends, challenges, technology adoption levels and solution landscape in at least one of the sub-sectors in Life Sciences and Healthcare Enterprise Technology and Transformation Strategy Ability to articulate leading business issues and trends including the associated technology implications Demonstrate application of business acumen while leveraging information technology Experience of being a Technology Product Owner and responsible for delivering product model and communicating the product needs with business partners Strong understanding of front to back architecture principles, technology stack, infrastructure with exposure to new age tools One life cycle project execution experience in recommending and/or implementing IT strategy and solutions for improving business outcomes Exposure to working in non-India Geographies (preferably the US) and / or interacting with Global stakeholders Candidates with project experience in one or more of the following areas is good to have: IT Strategy & Alignment – Delivering IT Strategy, driven both from a top-down analysis starting with an articulated business strategy and a bottom-up technology capability analysis; Experience working on cost reduction techniques, portfolio modernization and delivery roadmap creation for LSHC players Technology Operating Model Design - Assessment of current state operating model -its underlying processes, ability to identify pain points and process gaps; design of target state operating model and associated roadmap Enterprise Architecture – Experience of Enterprise Architecture capabilities such as Blueprinting, solution architecture, architecture assessment, planning and cost estimation. Knowledge of any of the major Enterprise Architecture Frameworks (preferred) E.g. TOGAF , FEA(F), and DoDAF. Experience with CTMS, LIMS, Compliance, GXP, MES, Argus, Oracle systems preferred IT Outsourcing: Experience working on IT Outsourcing model, CROs, BPOs etc. vendor analysis and benchmarking, contract analysis and understanding of how IT resources create shareholder (business) value Enterprise Data Management & Governance : Strong understanding of data management process across the data lifecycle (MDM, ingestion, storage, transformation) with experience in evaluating the client's data landscape and architecture to identify opportunities for improvement. Assessing current data governance practices and maturity within client organizations, having the ability to define and implement data governance strategies and frameworks for organizations. Additionally, having regulatory experience such as those of US FDA, EMEA, and DCGI are desirable AI/ML – Strong understanding of AI/ML concepts and frameworks, ability to design solutions around automation including advanced AI / ML solutions in areas of deep learning, machine learning, NLP, Simulation etc.; knowledge of AI/ML implementation use cases for players in LSHC industry (e.g., impact of Gen AI on healthcare value chain, specifically in R&D, manufacturing and commercialization of the drug) Cloud Strategy – Understand the impact of cloud computing in business and technology decisions, ability to identify and articulate the business and technology drivers of cloud computing, design of business cases for cloud. Certifications such as AWS, GCP, Azure will be a plus. Experience with workload assessment, business cases development, operational assessment, roadmap creation, vendor selection DevOps / Agile – Strong understanding of Agile, DevOps, CI/CD, Site Reliability Engineering with hands on experience on tools such as Jenkins, Git and JIRA Core Consulting Skills Clear and concise communication - conduct client interviews, participate in workshops/trainings and present recommendations. Good client presence – interact and build relationships with clients and other team members Analytical thinking - ability to perform detailed, quantitative analysis and research (primary and secondary). Synthesize and present insights and recommendations from data. Logical structuring - structured approach to problem solving and ability to perform root cause analysis of client problems Deadline-oriented and quality focused - develop and own development of deliverables. Own and manage specific work-thread, develop plans for components of engagement, manage and mentor junior resources Collaboration - Be able to work both independently and as part of a team with professionals at all levels. Be able to prioritize tasks, manage change in scope, work on multiple assignments, and raise concerns/questions where appropriate Network - ability to chart one’s own career and build networks within the organization Qualifications Required: MBA, MS, M. Tech., or PHD from a premier school in India or abroad. Educational background in Biotech / Pharmaceutical / Biomedical / Biochemistry / Bioinformatics / Biostatistics preferred 1-3 years of relevant experience post MBA / MS / MTech 1-2 years with LSHC industry focus Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Professional development At Deloitte, professionals have the opportunity to work with some of the best and discover what works best for them. Here, we prioritize professional growth, offering diverse learning and networking opportunities to help accelerate careers and enhance leadership skills. Our state-of-the-art DU: The Leadership Center in India, located in Hyderabad, represents a tangible symbol of our commitment to the holistic growth and development of our people. Explore DU: The Leadership Center in India . Benefits To Help You Thrive At Deloitte, we know that great people make a great organization. Our comprehensive rewards program helps us deliver a distinctly Deloitte experience that helps that empowers our professionals to thrive mentally, physically, and financially—and live their purpose. To support our professionals and their loved ones, we offer a broad range of benefits. Eligibility requirements may be based on role, tenure, type of employment and/ or other criteria. Learn more about what working at Deloitte can mean for you. Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Requisition code: 306021

The Senior Biostatistician plays a pivotal role in the research and development of clinical projects by applying statistical methods and providing insights through data analysis. This position requires expertise in R programming and a deep understanding of statistical techniques such as Analysis of Variance (ANOVA) and Analysis of Covariance (ANCOVA). The Senior Biostatistician will not only collaborate with various teams to ensure compliance with regulatory standards but also contribute to the development of statistical analysis plans and the interpretation of results. Given the importance of accurate statistical evaluations in clinical trials, this role is critical to the decision-making processes that impact patient outcomes and the overall success of pharmaceutical developments. You will lead projects and mentor junior biostatisticians, making your contribution vital to enhancing the organization's capabilities and ensuring the integrity of research findings. Develop and implement statistical analysis plans for clinical studies. Perform statistical analyses using R, focusing on ADaM, ANOVA, and ANCOVA methodologies. Collaborate with clinical research teams to define analysis objectives and timelines. Create and validate datasets to ensure accuracy and compliance with regulatory standards. Generate and interpret statistical results to contribute to clinical study reports. Work closely with data managers to design data collection tools and processes. Conduct exploratory data analyses and prepare visualizations to communicate findings effectively. Participate in protocol development and provide statistical input on study design. Mentor and supervise junior statisticians and biostatisticians. Conduct peer reviews of statistical analyses and reports executed by peers. Stay current with biostatistics trends, methodologies, and regulatory guidance. Present statistical findings to stakeholders and at scientific meetings. Assist in regulatory submissions by preparing statistical sections of FDA submissions and other documents. Participate in interdisciplinary project meetings and collaborate with cross-functional teams. Continuously improve statistical practices and methodologies within the team. Required Qualifications Master's or PhD in Biostatistics, Statistics, or related field. Minimum of 5 years of experience in a biostatistical role within the pharmaceutical or biotechnology industry. Proficiency in R programming for statistical computing and data visualization. Experience with ADaM data standards and regulatory guidelines. Strong knowledge of ANOVA, ANCOVA, and other statistical methodologies. Excellent understanding of clinical trial design and regulatory requirements. Proficiency in other statistical software such as SAS is highly desirable. Exceptional analytical and problem-solving skills. Ability to communicate complex statistical concepts to non-statistical audiences. Experience in leading statistical analyses for multiple clinical projects simultaneously. Strong attention to detail and commitment to data integrity. Demonstrated ability to work collaboratively within a team environment. Experience mentoring or training junior staff members. Published research or contributions to scientific literature is a plus. Excellent organizational and time management skills. Strong interpersonal skills and ability to work in a diverse environment.,

About The Team In this role, you will be part of the Global Distribution Management team, with responsibility to support all efforts to enhance the team's effectiveness by driving and improving operational processes You would be required to coordinate our efforts and actions across teams, keeping constant customer and broker focus with particular emphasis on improving the features on the CRM application, managing data quality within the application, setting up processes for manual data operations and supporting other operational activities, About The Role Analyze and test both new and existing features in internal CRM digital applications, Develop and maintain reports & trackers to monitor performance and effectiveness Develop detailed dashboards to track business objectives whenever required, Understand the customer journey and be able to provide recommendations for improvement, Perform routine checks on the application features Investigate and diagnose frontend application faults and errors, Monitor, record and respond to requests for support for the features in the CRM systems, Account and Partner management within CRM system, Communicate messages regarding systems issues to users promptly, Maintain documentation of key databases and linked applications, Manage Invoicing and accrual processes for the cost center, Enhance workflow and cross-team engagements, About You Degree in business administration or a related field required, 2+ years of experience as an operations analyst or in a similar position, Excellent communication skills, both verbal and written, Good working knowledge in excel Experience in working with databases and CRM tools Knowledge of SQL, Python (beginner) would be preferred, Basic financial knowledge would be an added advantage, Strong analytical and critical thinking skills, Strong multitasking and time management skills, About Swiss Re Corporate Solutions Swiss Re is one of the worlds leading providers of reinsurance, insurance and other forms of insurance-based risk transfer We anticipate and manage risks, from natural catastrophes and climate change to cybercrime, Swiss Re Corporate Solutions is the commercial insurance arm of the Swiss Re Group We offer innovative insurance solutions to large and midsized multinational corporations from our approximately 50 locations worldwide We help clients mitigate their risk exposure, whilst our industry-leading claims service provides them with additional peace of mind, Our success depends on our ability to build an inclusive culture encouraging fresh perspectives and innovative thinking Swiss Re Corporate Solutions embraces a workplace where everyone has equal opportunities to thrive and develop professionally regardless of their age, gender, race, ethnicity, gender identity and/or expression, sexual orientation, physical or mental ability, skillset, thought or other characteristics In our inclusive and flexible environment everyone can bring their authentic selves to work and their passion for sustainability, If you are an experienced professional returning to the workforce after a career break, we encourage you to apply for open positions that match your skills and experience, Keywords Reference Code: 135006

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team. The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. Position provides support in Request for Proposals (RFPs) and presents at Business Development (BD) Meetings. **This position is for the Bengaluru Location and not home-based** In this role your key tasks will include: Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites). Plan and project the resources required including management of tasks, timelines, risk and quality. Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition. Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements. Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements. Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs). Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed. Create training materials for EDC users and provide project-specific training as required. Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness. Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock). Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data. Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance. Organize and lead Quality Review activities during study. Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA). Manage the database maintenance, lock and close-out processes and procedure. Participate in conference calls and/or meetings with vendors and sponsors. Recognize and solve potential problems and evaluate effectiveness. Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date. Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned. Help to align data management and clinical programming best practices, standards and conventions within the company. Provide leadership, expertise and support to other department members. Propose and support initiatives for improving efficiency. Actively support to staff learning & development within the company. Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions . Represent the company at professional meetings, webinars or seminars. Train and mentor data management staff, support in development of new training material and provide training to relevant staff. Participate in the interview process for new recruits. Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes. Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients. Contribute to and take part in client evaluations and visits. Support in preparation of new proposals and budgets for Data Management services. Requirements To be successful you should possess: Life science, healthcare degree and/or combination of education and experience. Minimum 7 years of relevant work experience asa Clinical Data Manager. Minimum 7 years of experience in drug development and/or clinical research. Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements. Good understanding of Medical Terminology. Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA. Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases. Experience in covering all phases of a clinical study (start up, conduct and database lock). Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation. Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models. Experience in developing data management standards. Strong written and verbal communication skills including a good command of the English language. Representative, outgoing and client-focused. Ability to work in a fast-paced challenging environment of a growing company. Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Administrative excellence. Attention to detail, strong technical, analytical and problem-solving skills. Strong project management skills. Ability to translate guidelines, rules and regulations in clear and usable recommendations. Ability to simplify complex issues into understandable concepts. Excellent organizational, negotiating and motivational skills. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers : "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

Summary Position Summary Job Description - Strategy & Transactions – Strategy (Consultant) At Deloitte Strategy & Transactions (S&T), we don’t just advise — we architect the future. Our team is uniquely positioned at the intersection of strategy and execution, empowering clients to tackle their most pressing challenges and unlock transformative growth. We work with C-suite executives, Boards, and business leaders to answer the questions that matter most — from navigating complex M&A and driving digital transformation, to reshaping operating models and unlocking new market opportunities. We are trusted advisors during our clients' most critical, high-stakes moments. But we don’t stop at client impact — we are equally passionate about investing in our people. At S&T, you’ll be part of a dynamic team culture that accelerates leadership development, fosters curiosity, and delivers hands-on experience at the forefront of strategy and transactions. We design differentiated career paths that empower our talent to thrive. Our capabilities span the full lifecycle of transformation — from Enterprise and Growth Strategy to Enterprise Technology and Transformation Strategy , end-to-end M&A, valuation and modeling, and performance improvement & restructuring, to infrastructure & real estate advisory and sustainability-driven innovation. If you’re looking to work where bold thinking meets real-world impact — and where your growth matters as much as your clients’ — Strategy & Transactions is your next move. The team Our Strategy practice brings together several key capabilities that will allow us to architect integrated programs that transform our clients’ businesses, including Corporate & Business Unit Strategy, Technology Strategy & Insights, Enterprise Model Design, Enterprise Cloud Strategy and Business Transformation. Strategy professionals will serve as trusted advisors to our clients, working with them to make clear data-driven choices about where to play and how to win, in order to drive growth and enterprise value. Work you will do: Deloitte’s ‘Strategy’ offering helps companies address the entire range of top management challenges including pursuing new growth opportunities, developing go-to-market strategies, channel strategies, and pricing strategies. Identify strategies for growth and value creation Develop the appropriate business models, technology operating models, and capabilities to support their strategic vision Maximize the ROI on technology investments and leverage technology trends to architect future technology strategies Required Experience And Skills Enterprise Technology and Transformation Strategy – Life Sciences and Health Care (LSHC) LSHC Industry Experience Consulting experience for clients in the Life Sciences and Healthcare industry Hands-on exposure of working for / with leading companies in the Life Sciences (Pharmaceutical / Biotech), US Provider and/or US Payor/Health Plan/PBM industries (minimum 1+ year of experience) Awareness of industry trends, challenges, technology adoption levels and solution landscape in at least one of the sub-sectors in Life Sciences and Healthcare Enterprise Technology and Transformation Strategy Ability to articulate leading business issues and trends including the associated technology implications Demonstrate application of business acumen while leveraging information technology Experience of being a Technology Product Owner and responsible for delivering product model and communicating the product needs with business partners Strong understanding of front to back architecture principles, technology stack, infrastructure with exposure to new age tools One life cycle project execution experience in recommending and/or implementing IT strategy and solutions for improving business outcomes Exposure to working in non-India Geographies (preferably the US) and / or interacting with Global stakeholders Candidates with project experience in one or more of the following areas is good to have: IT Strategy & Alignment – Delivering IT Strategy, driven both from a top-down analysis starting with an articulated business strategy and a bottom-up technology capability analysis; Experience working on cost reduction techniques, portfolio modernization and delivery roadmap creation for LSHC players Technology Operating Model Design - Assessment of current state operating model -its underlying processes, ability to identify pain points and process gaps; design of target state operating model and associated roadmap Enterprise Architecture – Experience of Enterprise Architecture capabilities such as Blueprinting, solution architecture, architecture assessment, planning and cost estimation. Knowledge of any of the major Enterprise Architecture Frameworks (preferred) E.g. TOGAF , FEA(F), and DoDAF. Experience with CTMS, LIMS, Compliance, GXP, MES, Argus, Oracle systems preferred IT Outsourcing: Experience working on IT Outsourcing model, CROs, BPOs etc. vendor analysis and benchmarking, contract analysis and understanding of how IT resources create shareholder (business) value Enterprise Data Management & Governance : Strong understanding of data management process across the data lifecycle (MDM, ingestion, storage, transformation) with experience in evaluating the client's data landscape and architecture to identify opportunities for improvement. Assessing current data governance practices and maturity within client organizations, having the ability to define and implement data governance strategies and frameworks for organizations. Additionally, having regulatory experience such as those of US FDA, EMEA, and DCGI are desirable AI/ML – Strong understanding of AI/ML concepts and frameworks, ability to design solutions around automation including advanced AI / ML solutions in areas of deep learning, machine learning, NLP, Simulation etc.; knowledge of AI/ML implementation use cases for players in LSHC industry (e.g., impact of Gen AI on healthcare value chain, specifically in R&D, manufacturing and commercialization of the drug) Cloud Strategy – Understand the impact of cloud computing in business and technology decisions, ability to identify and articulate the business and technology drivers of cloud computing, design of business cases for cloud. Certifications such as AWS, GCP, Azure will be a plus. Experience with workload assessment, business cases development, operational assessment, roadmap creation, vendor selection DevOps / Agile – Strong understanding of Agile, DevOps, CI/CD, Site Reliability Engineering with hands on experience on tools such as Jenkins, Git and JIRA Core Consulting Skills Clear and concise communication - conduct client interviews, participate in workshops/trainings and present recommendations. Good client presence – interact and build relationships with clients and other team members Analytical thinking - ability to perform detailed, quantitative analysis and research (primary and secondary). Synthesize and present insights and recommendations from data. Logical structuring - structured approach to problem solving and ability to perform root cause analysis of client problems Deadline-oriented and quality focused - develop and own development of deliverables. Own and manage specific work-thread, develop plans for components of engagement, manage and mentor junior resources Collaboration - Be able to work both independently and as part of a team with professionals at all levels. Be able to prioritize tasks, manage change in scope, work on multiple assignments, and raise concerns/questions where appropriate Network - ability to chart one’s own career and build networks within the organization Qualifications Required: MBA, MS, M. Tech., or PHD from a premier school in India or abroad. Educational background in Biotech / Pharmaceutical / Biomedical / Biochemistry / Bioinformatics / Biostatistics preferred 1-3 years of relevant experience post MBA / MS / MTech 1-2 years with LSHC industry focus Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Professional development At Deloitte, professionals have the opportunity to work with some of the best and discover what works best for them. Here, we prioritize professional growth, offering diverse learning and networking opportunities to help accelerate careers and enhance leadership skills. Our state-of-the-art DU: The Leadership Center in India, located in Hyderabad, represents a tangible symbol of our commitment to the holistic growth and development of our people. Explore DU: The Leadership Center in India . Benefits To Help You Thrive At Deloitte, we know that great people make a great organization. Our comprehensive rewards program helps us deliver a distinctly Deloitte experience that helps that empowers our professionals to thrive mentally, physically, and financially—and live their purpose. To support our professionals and their loved ones, we offer a broad range of benefits. Eligibility requirements may be based on role, tenure, type of employment and/ or other criteria. Learn more about what working at Deloitte can mean for you. Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Requisition code: 306021

Sponsor-dedicated JOB DESCRIPTION Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials. Responsibilities As a Principal Statistical Programmer, your responsibilities will include: Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs Participate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions. Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros Participate in the development of CRFs, edit check specifications, and data validation plans Provide review and/or author data transfer specifications for external vendor data Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices Qualifications Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities Must be able to work independently Outstanding communication skills (written and verbal) and strong leadership skills Preferred Qualifications (nice To Have) Prior work experience with pharmacokinetic data and the neuroscience field, proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)