510 Biostatistics Jobs - Page 2

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)

Demonstrator (NM) for the Department of Biostatistics Qualification: M.Sc., (Biostatistics) / M.Sc., (Statistics) Salary: As per institutional Rule Candidates should handle Biostatistics classes for M.Sc., Biostatistics, Nursing & AHS students and offer statistical consultation to PGs, faculties, etc.

Overview Please Note: You may be required to travel to our Mumbai office based on business requirements or for company/team events. If you are looking for challenging and rewarding work which combines your understanding of medical science and aptitude for writing into one unique job, the Medical Writer role is for you. This is an opportunity to grow your career and make a greater impact on the lives around you. Responsibilities Use scientific expertise to develop (write, proofread, and data-check) high-quality, client-ready scientific, medical, and educational materials like slides, abstracts, posters, manuscripts, MSL/training slide decks, infographics, congress and meetings materials, literature searches and reviews, standard response letters/medical information letters, and HCP engagement content according to client needs with excellent attention to detail under the guidance of the scientific leads Liaise and build trusting and professional relationships with international pharmaceutical clients, healthcare professionals, internal and external stakeholders including authors, reviewers and key opinion leaders across therapeutic areas -- learning to anticipate their needs Effectively and proactively communicate with team members, authors/faculty, clients and vendors Attend workshops/seminars/trainings to hone your skills and contribute to organizational objectives Attend client and other external meetings and supporting senior team members as needed Apply your scientific and creative knowledge and work closely with client directors in developing ideas and executing effective medical communications initiatives in the digital space, including publication extenders, creation of infographics, interactive assets, website content, patient narratives, and medical information engagement plans You will be responsible for ensuring all materials follow/comply with client requirements/SOPs, style guides, client templates, client preferences (as applicable), and CACTUS internal SOPs. Any updates to either of these items should be made consistently and documents should remain up to date Perform as a document specialist, provide intellectual input across document types, and contribute to making cutting-edge research accessible to specific audiences as appropriate, by maintaining current awareness of developments across therapeutic areas or disciplines Share best practices and client preferences, thereby contributing to skill development within the medical communications team #Li-Remote Qualifications and Prerequisites 1-3 years of experience in relevant fields of scientific writing PhD/MD (Pharmacology) OR PhD (Life Sciences) OR PharmD with a good understanding of clinical research and medical communication Should have experience working on publications Clear, concise, scientific style of writing, with a high level of attention to detail and excellent language skills Excellent communication skills, especially with the clients Ability to adapt writing style to different materials and target audiences Basic knowledge of biostatistics Literature reviewing and evaluation capabilities Very good working knowledge of MS Office Application Process Before applying, please ensure you meet the role requirements listed above and have legal authorization to work in the country where this role is advertised. Our selection process typically involves an initial screening by a recruiter, a technical assessment, and two to three interview rounds. Equal Opportunity Our hiring practices reflect our commitment to providing equal opportunities and creating an environment where everyone can thrive, develop, and succeed. We celebrate the uniqueness of our team members and prohibit discrimination of any kind, based on race, color, religion, gender identity, sexual orientation, age, marital status, disability, or any other protected characteristic. Accelerating from Anywhere As a remote-first organization, these are essential attributes we look for in all our candidates. Taking ownership of your work with minimal supervision, showing strong ability to organize, prioritize and deliver results independently. Documenting work that brings everyone on the same page. Maturity to choose between synchronous and asynchronous collaboration. Effectively collaborating with colleagues across different time zones by setting dedicated hours for collaboration and keeping team members updated through your MS Teams status. About CACTUS At Cactus Life Sciences (cactuslifesciences.com), we believe the future of medical communications lies at the intersection of science, technology, and human connection. Headquartered in Princeton, New Jersey, with teams in Switzerland, the United Kingdom, India, and Japan, we help biopharmaceutical organizations redefine scientific exchange-leveraging AI, automation, and innovation while keeping patients at the heart of everything we do. Our expertise spans medical strategy, scientific content development, and medical education across therapeutic areas and the product lifecycle. By blending scientific rigor, agile operational models, and future-ready technologies, we partner with medical affairs teams to catalyze their transformation, adapt to a changing landscape, and drive meaningful outcomes for healthcare communities worldwide.

Overview If you are looking for challenging and rewarding work which combines your understanding of medical science and aptitude for writing into one unique job, the Associate Medical Writer role is for you. This is an opportunity to grow your career and make a greater impact on the lives around you. Please Note: CactusLife Sciences is a remote-first organization and we embrace an accelerate from anywhere culture. You may be required to travel to our Mumbai office based on business requirements or for company/team events. Responsibilities Use scientific expertise to develop high-quality, publication-ready scientific documents for SciComms and Medical Information clientele, including MSL slide decks, infographics, congress materials, literature searches, standard response letters/medical information letters, abstracts, posters, manuscripts, and HCP engagement content according to client needs under the guidance of the scientific leads with excellent attention to detail. Work with international pharmaceutical clients and liaise with internal and external stakeholders including authors, reviewers and key opinion leaders across therapeutic areas with guidance from scientific leads. Effectively and proactively communicate with team members, authors/faculty, clients and vendors. Attend workshops/seminars/trainings to hone your skills and contribute to organizational objectives. Proofreading and data-checking of scientific documents. Attending client and other external meetings and supporting senior team members as needed. Qualifications and Prerequisites 1+ years of experience in relevant fields of scientific writing. PhD/MD (Pharmacology) OR PhD (Life Sciences) OR PharmD OR MPharm/M.Sc with a good understanding of clinical research and medical communication. Clear, concise, scientific style of writing, with a high level of attention to detail and excellent language skills. Ability to adapt writing style to different materials and target audiences. Basic knowledge of biostatistics. Literature reviewing and evaluation capabilities. Very good working knowledge of MS Office. Application Process Before applying, please ensure you meet the role requirements listed above and have legal authorization to work in the country where this role is advertised. Our selection process typically involves an initial screening by a recruiter, a technical assessment, and two to three interview rounds. For this role, the process starts with a Technical Interview with the hiring managers, followed by a Technical Assessment, where candidates will have agreed upon timeline to complete the task. The final round will be the HR Interview. All interactions will be conducted virtually via MS Teams. Equal Opportunity Our hiring practices reflect our commitment to providing equal opportunities and creating an environment where everyone can thrive, develop, and succeed. We celebrate the uniqueness of our team members and prohibit discrimination of any kind, based on race, color, religion, gender identity, sexual orientation, age, marital status, disability, or any other protected characteristic. Accelerating from Anywhere As a remote-first organization, these are essential attributes we look for in all our candidates. Taking ownership of your work with minimal supervision, showing strong ability to organize, prioritize and deliver results independently. Documenting work that brings everyone on the same page. Maturity to choose between synchronous and asynchronous collaboration. Effectively collaborating with colleagues across different time zones by setting dedicated hours for collaboration and keeping team members updated through your MS Teams status. About CACTUS At Cactus Life Sciences (cactuslifesciences.com), we believe the future of medical communications lies at the intersection of science, technology, and human connection. Headquartered in Princeton, New Jersey, with teams in Switzerland, the United Kingdom, India, and Japan, we help biopharmaceutical organizations redefine scientific exchange-leveraging AI, automation, and innovation while keeping patients at the heart of everything we do. Our expertise spans medical strategy, scientific content development, and medical education across therapeutic areas and the product lifecycle. By blending scientific rigor, agile operational models, and future-ready technologies, we partner with medical affairs teams to catalyze their transformation, adapt to a changing landscape, and drive meaningful outcomes for healthcare communities worldwide.

Kenvue is currently recruiting for a: Principal Biostatistician What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. Role reports to: Global BioStats, Data Mgmt & Prog Location: Asia Pacific, India, Karnataka, Bangalore Work Location: Hybrid What you will do Who we are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson’s and BAND-AID® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. Principal Biostatistician manages the operations of the biostatistics functions of the department, including activities related to the design and analysis of clinical trials, data submission and ensure the project success, support the data interpretation and date reporting activities and publication strategy. Responsibilities will include but not limited to Collaborate with resources from functional organizations and outside sources to ensure project success. Function as Lead Subject Matter Expert (Lead SME) with respect to application of statistical techniques, with related responsibilities governed by applicable procedures. Support the design and analysis of clinical trials. Provide oversight of statistical activities at the project level. Ensure compliance with all statistical analysis and reporting procedures. Participate in sponsor oversight of Biostatistics vendor activities. Assist clinical investigators with biostatistics work and the creation of publications and manuscripts. Provide support for interactions with and submissions to regulatory agencies. Required Qualifications Graduate degree in Statistics or a related quantitative field with sufficient concentration in statistics Typically requires 4+ years of industry experience with PhD degree or equivalent, and 6+ years of industry experience with MS degree or equivalent Physical Demands: Office setting. Travel < 15%. Pharmaceutical industry experience in clinical development biostatistics methods and processes SAS programming experience. Excellent oral and written communication skills, and strong interpersonal skills Excellent problem-solving skills Effective collaboration in cross-functional teams Serve as role model for making Credo-based decisions Support, influence, or create a trusting, collaborative, and ethical work environment Maintain the highest standards of ethics, quality, compliance, and accountability Maintain awareness of the external environment, adding value and insights Use insights to uncover important unmet needs Encourage and support internal collaboration across levels, creating effective solutions Contribute to innovative and viable products, services, and/or solutions, adding value Challenge the status quo, and adapt to change Identify and communicate meaningful risks, and take appropriate action Take accountability for own performance and development of self, and support talent acquisition and others' development Leverage diverse perspectives, backgrounds, and talent to generate effective ideas or solutions Engage in transparent and constructive conversations Act with speed, agility, and accountability Make effective decisions and take actions based on how work impacts the enterprise Manage priorities effectively to deliver expected results Competencies Solid statistical background, with application to clinical trials preferred Scientific curiosity, eagerness to grow in statistical knowledge and applications Excellent team player Excellent communication skills If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

3 Research Associates for the Biomedical Informatics Unit (Job Code - 1617) Biomedical Informatics Unit of CMC Vellore is looking for 3 Research Associates to work on Data Science, AI / ML Projects in the unit. Duration: 1 Year Qualifications: B. Tech. / M. Tech / MS / MCA / M.Sc. in Computer Science, Data Science, Biostatistics, Biotechnology, or related fields. Essential Skills: Strong Programming in Python, experience with open - source databases, and familiarity with AI / ML frameworks. Mandatory: Certified skills in AI / ML with minimum of 1 year prior experience in handling real - world healthcare data projects. Desirable: Proven writing skills for technical and / or general audience Salary: Consolidated, commensurate with experience Mode of Appointment: Project Accommodation : Not Provided

Job Id 290141 Hyderabad, Andra Pradesh, India Job Type Full-time Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Scientific Director, Clinical Pharmacology Scientific Director, Clinical Pharmacology position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization is a strategic, scientific, and cross-functional role, leading the Clinical Pharmacology (CP) Expert Team, responsible for developing and executing clinical pharmacology and Model Informed Drug Development (MIDD) strategies from the early to late-stage clinical development. This role represents the CP Expert Team to the global cross functional drug discovery and development project teams, in close collaboration with colleagues in Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization. The CP Expert Team Lead provides strong leadership for integrating individual functional contributions, developing clinical pharmacology strategy in alignment with the overall clinical development plan, and executing the program strategy/plan. The scope includes programs from exploratory development (ED) through life cycle management, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas. KEY ACCOUNTABILITIES Ensures that CP strategy is developed, aligned (with cross-functional development plans), endorsed and executed to support the indication, patient population, and phase of development while taking into account the competitive landscape Represent clinical pharmacology and promote MIDD with internal and external stakeholders Provides in-depth CP, PK and PK/PD advice and expertise and lead clinical pharmacology expert team and deliver on Dose and posology decisions, from FIH starting dose through submission and beyond Fit-for-purpose CP package including dose, dose regimen, and adjustment for specific conditions and specific populations, exposure-QTc assessment and immunogenicity assessment in collaboration with other function lines at appropriate stages of development Develop and execute MIDD strategies/plans in collaboration with pharmacometrics and other functions PK/PD data analysis, interpretation, and presentation Related sections of major clinical and regulatory documents (e.g. clinical protocols, IBs, CTDs, INDs, NDAs, IMPDs, briefing books) Contribute to due diligence projects, if needed EDUCATION/LANGUAGES 7+ years (Bio)pharmaceutical industry and/or postdoctoral experiences with clinical drug development experience Doctorate degree (PhD, PharmD or MD) relevant in the related disciplines of clinical pharmacology, pharmaceutics, pharmacometrics, statistics, engineering or mathematics Fluency in English PROFESSIONAL SKILLS & EXPERIENCE Strong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas. Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc. Excellent knowledge of regulatory requirements and submission across the main regions Good understanding about translational sciences such as quantitative pharmacology, safety and biomarkers. Clear evidence of ability to adapt to changing business needs by prioritizing multiple tasks. General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus. Hands on modeling expertise is a plus. Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment. Demonstrated ability for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results. Strong presentation, communication, and organization skills. Ability to communicate technical results to stakeholders. have a broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative & strategic capabilities. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity! US Equal Employment Opportunities The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. Notice on Fraudulent Job Offers Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information here. Applicant Profile Along with our brand-new career site, we've also revamped our application process. If you've applied for a position before April 16th 2025, you can log into your old profile to see the status of past applications. For the application you’ve will completed, and any in the future, you can create a new profile to check in on your status. WHAT WE OFFER Money makes the world go round. But at our company there’s more than just financial rewards. We offer a range of attractive benefits to help you work your magic. Saving & Finacial Our 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year. We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future. Health & Wellness We offer comprehensive medical, dental, & vision coverage-including virtual care through Telehealth & free behavioral health counseling sessions through our Employee Assistance Program. We also offer a wellness incentive program and personalized support to help you navigate and use your benefits. Voluntary Benefits Our voluntary benefits provide additional protection from the high costs of healthcare not covered by health insurance. We also have discount programs that offer exclusive savings on everything from auto, home, and pet insurance to low-interest personal loans. Work/Life Support We have several programs to support your work/life balance, including generous paid time off, back-up day care services, education assistance, and more. OUR RECRUITING PROCESS Depending on the position (level, functional area, country) the process can vary slightly. You apply Complete your online application for your preferred role(s) that match your interests and qualification. If you cannot find a suitable role please join our Talent Zone and stay connected for your next career opportunity. We screen We review your application and if we determine that you are a good fit we will move you to the selection process. We assess You are interviewed by phone, via video and/or face to face. Mutual agreement Ideally you are the perfect match for us! We hope you consider us as your new employer. Work your magic! To guarantee you a smooth start our onboarding preparation begins. Haven’t found the right job yet? Join our Talent Community to stay connected and explore future opportunities.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Data Analytics & Computational Sciences Job Sub Function Biostatistics Job Category Scientific/Technology All Job Posting Locations: Mumbai, India Job Description Principal Responsibilities: Responsible for planning, programming strategy, coordination, oversight, and execution of team activities following J&J IM and industry standards for one or more clinical trials or projects. Designs and develops programs in support of complex clinical data analysis and reporting activities. Supports submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages and reviewer’s guides. Provides technical and project-specific guidance to team members, ensuring high-quality, efficiency and on-time deliverables in compliance with departmental processes and procedures. Ensures use of latest standards and deployment of current technologies. Collaborates effectively with cross-functional team, counterparts, vendors to achieve project goals and manages escalations independently. Supports submission activities while ensuring the highest level of consistency and quality across trials by creating efficiencies in clinical data flow and implementing metadata-driven approaches. As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality. May play the role of a Delivery Unit/Disease Area Expert contributing to standards strategy and providing expertise for a specific Delivery Unit/Disease area across value streams in support of clinical programs including submissions. Contributes to departmental innovation and process improvement projects by supporting and/or leading developing and implementing processes, systems, and tool improvement initiatives. Clinical Programming Ensures the utilization of latest standards and technologies, adhering to regulatory requirements, and creating effective mapping algorithms and Data Review Model (DRM) and designs mapping algorithms for non-standard conversions as needed. Supports data cleaning by programming edit checks and data review listings and data reporting by creating data visualizations and listings for data management, medical monitoring, and central monitoring. Principal Relationships This role reports into a people manager position within the Delivery unit and is accountable to the Portfolio Lead for assigned activities and responsibilities. Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations. Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources. External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups. Education And Experience Requirements Bachelor’s degree or higher and/or equivalent in computer science, mathematics, data science/analytics/data engineering, public health, or other relevant scientific field (or equivalent theoretical/technical depth). Experience And Skills Required Approx. 4+ years programming and or clinical data management experience with increasing responsibility preferably in pharmaceutical/clinical trial environment. Knowledge of programming practices (including tools and processes). Knowledge of data structures and relevant programming languages for data manipulation/statistical analysis and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required. Expert CDISC Standards knowledge. Experience in planning and coordinating programming activities and leading teams. Experience working with cross functional stakeholders and teams. Experience in vendor management oversight. Project management skills and knowledge of team management principles. Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Demonstrated written and verbal communication skills.

CCTM, Bangalore, Remote/Office-based ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Centralized Clinical Trial Manager to join our diverse and dynamic team. As a Centralized Clinical Trial Manager at ICON, you will play a crucial role in overseeing the centralized monitoring activities of clinical trials, ensuring the smooth coordination of data-driven insights to enhance trial quality and patient safety. You will contribute to the advancement of innovative treatments and therapies by managing centralized trial activities and collaborating with cross-functional teams to ensure study compliance and efficiency. What You Will Be Doing Leading the centralized monitoring activities for clinical trials, including data review and risk-based monitoring. Collaborating with clinical operations, data management, and biostatistics teams to identify potential risks and ensure proactive management of trial data. Ensuring study compliance with regulatory requirements and protocols by overseeing real-time data reviews and monitoring activities. Providing oversight on site performance, patient safety, and data quality through centralized data insights and analytics. Coordinating with cross-functional teams to ensure efficient execution of clinical trials and contribute to continuous improvement in trial processes. Your Profile: Bachelor’s degree in life sciences, healthcare, or a related field (advanced degree preferred). Experience in clinical trial management, centralized monitoring, or data management, with a solid understanding of risk-based monitoring approaches. Strong analytical skills with proficiency in clinical trial data review and interpretation. Excellent organizational and project management skills, with the ability to manage multiple studies and meet deadlines. Effective communication and interpersonal skills, with the ability to collaborate across diverse teams and functions. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Purpose The role of the Principal Statistician is to provide statistical support to the statistics and programming department across a range of projects, clients and therapeutic areas. The Principal Statistician may also perform a supervisory role (e.g. line management and/or project management). Key Responsibilities Development of Methods Table: The candidate will lead the effort to develop and refine versions of the methods table, which will list methodologies required for clinical trial reporting and align those methods to existing R packages or identify gaps to be filled. Collaboration with various SMEs and regular reviews with experts will be essential. Package Review: - The candidate should be capable of conducting package reviews from a statistical methods perspective - While the candidate may not be an expert in all areas, they must proactively engage relevant experts when needed - Responsibilities include (as required) reviewing journal publications, conducting simulations (if required), and assessing whether the methods applied in the package align with the latest capabilities or improve upon current state-of-the-art tools. Prioritization of Package Evaluation: The candidate will help prioritize package evaluations, which may involve liaising with respective PS or SLS teams. They will recommend project teams based on available alternatives in the methods table, which will involve interaction with SMEs and package development teams. Strategic Communications: This individual will partner with client on communications at the Stats VP level, highlighting progress, focus areas, and key updates. Desired Capabilities: Strong statistical methods expertise with the ability to quickly learn and apply new methodologies. Solid knowledge of clinical study reporting, including inferential and modeling perspectives. Proficiency in R, with practical experience using diverse R packages. Working knowledge of SAS, ideally with an understanding of how Stats PROC aligns with statistical methods to help identify corresponding R packages. Technical: Perform technical review and provide input into clinical trial documents including protocols, CRFs, CSRs Author and review study SAP, TFL shells and dataset specifications Support study and/or compound level activities advising on study design and statistical issues across phases and therapeutic areas Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice Application of complex statistical techniques (e.g. mixed effects, non-linear modelling, Bayesian, advanced survival), model checking and interpretation Identify and implement appropriate sample size method using software or simulations Identify data and standards issues and resolve or escalate as appropriate Awareness of emerging standards and associated impact to ongoing and future planned trials Maintain proficiency in statistical methodology Maintain study master file documents and any other documents that are required to be audit ready People Management: Line management of statisticians, programmers and other technical staff. Accountable for overall performance of direct reports Provide coaching and mentoring of staff to achieve excellence. Direct employee career development and ensure line reports receive appropriate training to perform their day-to-day jobs Interview and effectively on-board and integrate new staff members Provide statistical technical leadership and coaching Project Management: Oversight of key client projects/portfolios. To include: Being Veramed Project Manager on client accounts and projects Maintain the project plan o Proactive management of resource, scope change and risks Manage the delivery of projects to budget Manage client expectations and issue resolution . General: Lead internal and client study, project and cross functional team meetings effectively Present study updates internally and at client meetings Share scientific, technical and practical knowledge within the team and with colleagues Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training Build effective collaborative working relationships with internal and client team members Ensure learnings are shared across projects or studies Develop and provide internal technical training where appropriate Lead process improvement initiatives Minimum Qualification Requirements MSc or PhD in Statistics/Biostatistics (or equivalent) At least 7 years of relevant industry experience Other Information/Additional Requirements Understanding of clinical drug development process, relevant disease areas, endpoints and different study designs Awareness of industry and project standards & ICH guidelines Excellent verbal and written communication skills Interpersonal/teamwork skills for effective interactions Proficiency in data handling using SAS or other statistical software (e.g. R) Self-management skills with a focus on results for timely and accurate completion of competing deliverables Demonstrated problem solving ability and attention to detail Ability to work independently and as part of a team Ability to manage a portfolio of projects and/or people Specific Key Responsibilities:

At GSK, we bring together science, technology, and talent to proactively combat diseases on a global scale, striving to improve the lives of millions of patients by constantly pushing the boundaries of respiratory science and infectious diseases, including vaccines and HIV. Our commitment to ESG leadership enables us to address some of society's most pressing challenges. We firmly believe that by working together, we can positively impact the health of over 2.5 billion people by the year 2031. When you embark on your journey at GSK, we enter into a mutual agreement. You pledge to embody our values and excel in our focus areas of Innovation, Performance, and Trust. In return, GSK is dedicated to fostering an environment where you can flourish. Together, we create a supportive ecosystem where each of us can thrive and concentrate on what truly matters to us. The primary responsibilities of the current role include leading a molecule from various quantitative strategy perspectives, overseeing a team of statisticians aligned with a specific disease area/research unit, and actively contributing to and steering organizational strategies at both global and India-level leadership teams (LT). Your role expectations encompass several key areas: **Statistical Expertise and Accountability:** - Ensuring top-notch statistical input throughout the design, execution, and interpretation of all statistical components in Medicine development at the molecule level. - Collaborating closely with cross-functional Project Team members to ensure project milestones are met within established quality, timeline, and budget parameters. - Upholding compliance expectations and regulatory requirements. **Technical Excellence:** - Demonstrating proficiency across a wide range of statistical methodologies, from established techniques to emerging approaches. - Applying optimal statistical and trial design methodologies while keeping abreast of methodologies used by other quantitative groups. - Committing to continuous learning and development in alignment with organizational objectives. **Science and Strategic Collaboration:** - Working with project and asset teams to optimize development strategies by leveraging diverse data sources. - Leveraging strong disease knowledge and competitor intelligence to drive data-driven decisions and solutions in drug development challenges. **Innovation and Problem Solving:** - Promoting innovation in evidence generation and clinical trial design by utilizing state-of-the-art statistical methods. - Contributing to problem-solving through advanced statistical approaches and fostering innovation in data utilization across development programs. **Communication and Influencing:** - Representing Biostatistics effectively in interactions with various stakeholders. - Articulating complex statistical concepts in a clear manner for non-statisticians. - Building and managing robust networks and relationships with key stakeholders to proactively influence project outcomes. **Leadership and People Development:** - Acting as an effective leader in business line and matrix roles. - Leading the development of Biostatistics talent and capabilities. - Setting clear objectives and priorities as a First Line Leader (FLL), actively engaging in development and performance goal-setting, and focusing on enhancing team capabilities. **Qualifications:** - Educational Background: PhD or Masters degree in Biostatistics, Statistics, Mathematics, or a related quantitative discipline. Advanced training in statistical methodologies, clinical trial design, or data science is preferred. - Technical Expertise: Strong foundation in statistical methodologies, proficiency in statistical programming environments such as R, and solid domain knowledge in drug development lifecycle. - Experience: 10-15 years of biostatistics experience in the pharmaceutical or healthcare industry, showcasing leadership in statistical strategies and innovative trial designs. At GSK, we are committed to fostering an inclusive environment where diversity is embraced, and reasonable adjustments are made during the recruitment process to support all candidates. If you require any accommodations, please reach out to our Recruitment Team at IN.recruitment-adjustments@gsk.com. Join us at GSK for the opportunity to unite science, technology, and talent to proactively combat diseases and positively impact the health of billions of people worldwide. Together, we can make a difference.,

As an Epidemiologist Health Data Scientist at WNS (Holdings) Limited, you will be responsible for assessing the feasibility of utilizing various real-world data sources, including electronic health records, registries, claims, and social media data. Your primary focus will be to support the generation of real-world evidence for consumer health products. Through this assessment, you will identify potential applications for Real-World Evidence (RWE) studies that leverage these data sources to facilitate research and decision-making processes. To excel in this role, you should hold a Master's or Ph.D. degree in Epidemiology, Biostatistics, or Health Data Science. Your expertise in these areas will enable you to contribute significantly to the advancement of healthcare research and the enhancement of consumer health products.,

Overview If you are looking for challenging and rewarding work which combines your understanding of medical science and aptitude for writing into one unique job, the Associate Medical Writer role is for you. This is an opportunity to grow your career and make a greater impact on the lives around you. Please Note: Cactus Life Sciences is a remote-first organization and we embrace an accelerate from anywhere culture. You may be required to travel to our Mumbai office based on business requirements or for company/team events. Responsibilities Use scientific expertise to develop high-quality, publication-ready scientific documents for SciComms and Medical Information clientele, including MSL slide decks, infographics, congress materials, literature searches, standard response letters/medical information letters, abstracts, posters, manuscripts, and HCP engagement content according to client needs under the guidance of the scientific leads with excellent attention to detail. Work with international pharmaceutical clients and liaise with internal and external stakeholders including authors, reviewers and key opinion leaders across therapeutic areas with guidance from scientific leads. Effectively and proactively communicate with team members, authors/faculty, clients and vendors. Attend workshops/seminars/trainings to hone your skills and contribute to organizational objectives. Proofreading and data-checking of scientific documents. Attending client and other external meetings and supporting senior team members as needed. Qualifications And Prerequisites 1+ years of experience in relevant fields of scientific writing. PhD/MD (Pharmacology) OR PhD (Life Sciences) OR PharmD OR MPharm/M.Sc with a good understanding of clinical research and medical communication. Clear, concise, scientific style of writing, with a high level of attention to detail and excellent language skills. Ability to adapt writing style to different materials and target audiences. Basic knowledge of biostatistics. Literature reviewing and evaluation capabilities. Very good working knowledge of MS Office. Application Process Before applying, please ensure you meet the role requirements listed above and have legal authorization to work in the country where this role is advertised. Our selection process typically involves an initial screening by a recruiter, a technical assessment, and two to three interview rounds. For this role, the process starts with a Technical Interview with the hiring managers, followed by a Technical Assessment, where candidates will have agreed upon timeline to complete the task. The final round will be the HR Interview. All interactions will be conducted virtually via MS Teams. Equal Opportunity Our hiring practices reflect our commitment to providing equal opportunities and creating an environment where everyone can thrive, develop, and succeed. We celebrate the uniqueness of our team members and prohibit discrimination of any kind, based on race, color, religion, gender identity, sexual orientation, age, marital status, disability, or any other protected characteristic. Accelerating from Anywhere As a remote-first organization, these are essential attributes we look for in all our candidates. Taking ownership of your work with minimal supervision, showing strong ability to organize, prioritize and deliver results independently. Documenting work that brings everyone on the same page. Maturity to choose between synchronous and asynchronous collaboration. Effectively collaborating with colleagues across different time zones by setting dedicated hours for collaboration and keeping team members updated through your MS Teams status. About CACTUS At Cactus Life Sciences (cactuslifesciences.com), we believe the future of medical communications lies at the intersection of science, technology, and human connection. Headquartered in Princeton, New Jersey, with teams in Switzerland, the United Kingdom, India, and Japan, we help biopharmaceutical organizations redefine scientific exchange—leveraging AI, automation, and innovation while keeping patients at the heart of everything we do. Our expertise spans medical strategy, scientific content development, and medical education across therapeutic areas and the product lifecycle. By blending scientific rigor, agile operational models, and future-ready technologies, we partner with medical affairs teams to catalyze their transformation, adapt to a changing landscape, and drive meaningful outcomes for healthcare communities worldwide.

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com. Job Summary The SAS Programmer will be responsible for providing SAS programming support for the Statistics and Data Management functions for all clinical trials and regulatory submissions. The candidate will work closely with Biostatisticians and Data Managers to create SAS programs for independently validating selected tables, listings, and figures and to assist with data cleaning and query generation. This position will also serve as a contact for programming activities being performed. Key Activities: • Perform data manipulation techniques and advanced techniques (arrays, transpositions, complex merges, SQL, SDTM etc.) and generic macro use and development to enable listing, table, and graph generation. • Involve in Statistical programming and validation of CDISC SDTM, Analysis Datasets (ADaM) and Tables, Listings, Graphs (TLG'S) • Analyze information and develop innovative solutions to programming and data analysis challenges. • Efficiently produce quality results under time constraints. • Successfully coordinate multiple priorities. • Based on experience, serve as the statistical programming lead on internal project teams and coordinate programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures. • Assist internal project team in identifying project priorities and communicating such activities and associated timelines to departmental management • Work independently to carry out assignments with occasional support from senior management. • Ensure the efficiency, quality, and integrity of data reporting and project activities executed. • Represent the department in client meetings/presentation and maintain a positive working relationship with sponsors, collaborating associate and vendor personnel. • Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks. • Contribute to on-going improvement of programming processes and methodology. • Perform other related duties as required by the Department. • Coach and advice junior programmers to identify problems and solutions • Ability to adapt and adjust to changing priorities • Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities, and deliverables. • Ability to fulfill ad hoc requests and perform high level review on deliverables. Required Skills/ Experience: • MSc in Biostatistics, Statistics, Computer Science, or related field. • 5-7 years of experience, to successfully perform the key responsibilities of the job • Experience leading statistical programming activities in clinical research for 5 + years experienced candidates. • SAS Certified Candidates preferred • Good understanding of Clinical Trials and the various terminologies • Experience leading statistical programming activities in clinical research • Previous experience in pharmaceutical research or CRO setting • Work within a team environment under extremely tight deadlines, and finish all TLGs ahead of schedule, despite severe data issues requiring multiple re-extractions and reruns • Knowledge of one or more statistical software packages (SAS® preferred) used to perform statistical analyses • Knowledge of CDISC services and hands on experience in developing SDTM datasets. • Good verbal and written communication • Positive attitude and willingness to learn and contribute to a team setting • Demonstrates ability to successfully lead a single project.

Job Details Position Title : Senior Analyst (Biostatistician) Experience : 5-10 Years Role : Fulltime / Permanent Location : Bangalore Work Mode: Hybrid Roles & Responsibilities : Generate statistical summary tables, patient data listings, and reports using SAS. Handle complex SAS programming issues , perform database and CRF review to ensure programming consistency, and be familiar with all study programming issues. Contribute to statistical analysis plans. Prepare template and programming for periodic progress reports for assigned clinical programs. Compile clinical data and relevant back-up material and present these results to the Biostatistics Manager for review. Work on SAS programs to generate data sets, tables, listings, and graphs. Work on SAS programs to complete quality control and validation work on SAS programs, data sets, and TLGs generated by others. Work on SAS programs to process and/or import external data into analysis data sets or export SAS output to other computer files for delivery. Work on SAS programs to create derived variables and data sets (e.g., LOCF (Last Observation Carry Forward), adverse events with multiple merging and cleaning procedures), or perform other required advanced data manipulation to support completion of biostatistics projects; SAS, SQL & Macro skills required. May be required to assist in other programming tasks using software other than SAS to support biostatistics or specialized data analysis requirements. Assist with documents to describe SAS programs as assigned, such as specifications for protocol analysis data sets. Perform group and departmental Quality Control (QC) procedures. Work on listings to support data cleaning and monitoring. Required Qualifications: Bachelor's Degree or equivalent in biostatistics, statistics, or related field The ideal candidate will have at least 5-8 years of experience in SAS programming and analysis of clinical trial data. Familiarity with clinical trial design and analysis issues. Experienced with electronic data capture (EDC) system(s). Preferred Qualifications: Medical device experience

Job Description Job Summary The SAS Programmer will be responsible for providing SAS programming support for the Statistics and Data Management functions for all clinical trials and regulatory submissions. The candidate will work closely with Biostatisticians and Data Managers to create SAS programs for independently validating selected tables, listings, and figures and to assist with data cleaning and query generation. This position will also serve as a contact for programming activities being performed. Key Activities: • Perform data manipulation techniques and advanced techniques (arrays, transpositions, complex merges, SQL, SDTM etc.) and generic macro use and development to enable listing, table, and graph generation. • Involve in Statistical programming and validation of CDISC SDTM, Analysis Datasets (ADaM) and Tables, Listings, Graphs (TLG'S) • Analyze information and develop innovative solutions to programming and data analysis challenges. • Efficiently produce quality results under time constraints. • Successfully coordinate multiple priorities. • Based on experience, serve as the statistical programming lead on internal project teams and coordinate programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures. • Assist internal project team in identifying project priorities and communicating such activities and associated timelines to departmental management • Work independently to carry out assignments with occasional support from senior management. • Ensure the efficiency, quality, and integrity of data reporting and project activities executed. • Represent the department in client meetings/presentation and maintain a positive working relationship with sponsors, collaborating associate and vendor personnel. • Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks. • Contribute to on-going improvement of programming processes and methodology. • Perform other related duties as required by the Department. • Coach and advice junior programmers to identify problems and solutions • Ability to adapt and adjust to changing priorities • Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities, and deliverables. • Ability to fulfill ad hoc requests and perform high level review on deliverables. Required Skills/ Experience: • MSc in Biostatistics, Statistics, Computer Science, or related field. • 5-7 years of experience, to successfully perform the key responsibilities of the job • Experience leading statistical programming activities in clinical research for 5 + years experienced candidates. • SAS Certified Candidates preferred • Good understanding of Clinical Trials and the various terminologies • Experience leading statistical programming activities in clinical research • Previous experience in pharmaceutical research or CRO setting • Work within a team environment under extremely tight deadlines, and finish all TLGs ahead of schedule, despite severe data issues requiring multiple re-extractions and reruns • Knowledge of one or more statistical software packages (SAS® preferred) used to perform statistical analyses • Knowledge of CDISC services and hands on experience in developing SDTM datasets. • Good verbal and written communication • Positive attitude and willingness to learn and contribute to a team setting • Demonstrates ability to successfully lead a single project.

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com. Job Summary The SAS Programmer will be responsible for providing SAS programming support for the Statistics and Data Management functions for all clinical trials and regulatory submissions. The candidate will work closely with Biostatisticians and Data Managers to create SAS programs for independently validating selected tables, listings, and figures and to assist with data cleaning and query generation. This position will also serve as a contact for programming activities being performed. Key Activities Perform data manipulation techniques and advanced techniques (arrays, transpositions, complex merges, SQL, SDTM etc.) and generic macro use and development to enable listing, table, and graph generation. Involve in Statistical programming and validation of CDISC SDTM, Analysis Datasets (ADaM) and Tables, Listings, Graphs (TLG'S) Analyze information and develop innovative solutions to programming and data analysis challenges. Efficiently produce quality results under time constraints. Successfully coordinate multiple priorities. Based on experience, serve as the statistical programming lead on internal project teams and coordinate programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures. Assist internal project team in identifying project priorities and communicating such activities and associated timelines to departmental management Work independently to carry out assignments with occasional support from senior management. Ensure the efficiency, quality, and integrity of data reporting and project activities executed. Represent the department in client meetings/presentation and maintain a positive working relationship with sponsors, collaborating associate and vendor personnel. Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks. Contribute to on-going improvement of programming processes and methodology. Perform other related duties as required by the Department. Coach and advice junior programmers to identify problems and solutions Ability to adapt and adjust to changing priorities Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities, and deliverables. Ability to fulfill ad hoc requests and perform high level review on deliverables. Required Skills/ Experience MSc in Biostatistics, Statistics, Computer Science, or related field. 5-7 years of experience, to successfully perform the key responsibilities of the job Experience leading statistical programming activities in clinical research for 5 + years experienced candidates. SAS Certified Candidates preferred Good understanding of Clinical Trials and the various terminologies Experience leading statistical programming activities in clinical research Previous experience in pharmaceutical research or CRO setting Work within a team environment under extremely tight deadlines, and finish all TLGs ahead of schedule, despite severe data issues requiring multiple re-extractions and reruns Knowledge of one or more statistical software packages (SAS® preferred) used to perform statistical analyses Knowledge of CDISC services and hands on experience in developing SDTM datasets. Good verbal and written communication Positive attitude and willingness to learn and contribute to a team setting Demonstrates ability to successfully lead a single project.

The Postdoctoral Fellow applicant will work in conjunction with the Principal Investigator to lead the Sex-Based Precision Medicine Research Core (SPMRC). The SPMRC will promote and support sex- and gender-based precision medicine (SPM) research at the Tulane Center of Biomedical Research Excellence in Sex-Based Precision Medicine (COBRE in SPM), assist Research Project Leaders (RPLs) and Pilot Project Leaders (PPLs) in obtaining independent research funding, and serve the broader scientific community by performing high-impact, sex-based biology and precision medicine (SPM) research. The study of sex and gender differences is a discipline in itself, with its own concepts and methods that apply across cells and tissues as well as clinical and population health. This critical aspect of SPM requires the use and knowledge of quantitative methods including biostatistics, epidemiology, and bioinformatics to design and analyze studies to assess the interactions of sex and gender with race, age, and social determinants of health (e.g., occupational hazards, lifestyle, social stresses, access to healthcare).

Who We Are Together, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Its a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the worlds leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organizations Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but were always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity The Director reports directly to the Head of Global Statistics, Data Science, and Medical Writing (GSD) and serves as a member of the GSD Leadership Team. This role oversees GSD India-based employees across Data Management, Statistics, Programming, and Medical Writing, managing key administrative responsibilities such as timesheet approvals, time-off requests, performance evaluations, and career development. The Director collaborates with HR to resolve employee concerns and partners with global functional heads for resource planning and assignments. While functional project leads provide day-to-day guidance, the Director ensures team members receive clear direction and coaching to support successful execution. A core focus of the role is fostering a unified GSD India community that is well-integrated with the global organization. In addition to operational leadership, the Director brings deep expertise in data functions, drug development, and clinical research, including regulatory interactions both within and outside the U.S. They provide strategic guidance across compounds or therapeutic areas, offering critical thinking that influences clinical development programs, study design, and analysis. The Director is well-versed in drug development principles, innovative trial approaches, and relevant tools and software. Strong communication skills and the ability to influence cross-functional teams are essential, as this role has significant visibility and impact across drug development programs and senior leadership How Youll Spend Your Day Provides strategic and scientific leadership to the clinical development, registration strategy, submission, health authority interactions, and medical affairs/market access plans for complex programs across multiple diseases Organizational leader that is a key contributor in defining and driving the line function strategy Leads and optimizes the contribution from the team(s) by collaborating and consulting with key partners, exhibiting a comprehensive understanding of drug development and associated operational requirements whilst demonstrating modern, enterprise, global leadership skills Strategic and/or managerial responsibilities for GSD India team across multiple programs/indications of Teva. Independently lead (large) programs and accountable for the GSD India deliveries and influence for the programs A modern drug development global leader operate as a full partner to clinical and scientific leadership. Ensures effective partnership with other functions including clinical, regulatory and other strategic functions to drive quantitative decision sciences / making in drug development and enable successful impact on CDPs (Clinical Development Plan), programs and trials Interacts and manages KOLs/CROs and represents the company in external scientific and industry forums Is seen as a strategic Business partner involved in high-level decisions having an impact on the organization globally Drives GSD India Team it through the use of novel/innovative clinical trial designs and statistical or other data related methodology Becomes proficient in the knowledge of the therapeutic area and competitive landscape of the specified therapeutic area Prepares, or oversees the preparation of, statistical sections of clinical protocols in collaboration with GSD global team and Clinical Research personnel as needed Supports due diligence activities Forecasts and maintains budgets Primarily works at the TA / Functional Level Oversee direct reports; Oversee contingent workers and/or vendors; Provide training to others; Strategically analyze needs to manage resources and accountable for resource allocation Accountable for delivering assignments with quality and within timelines Your Experience And Qualifications Ph.D./MS in Statistics/Biostatistics (or data related field or Medical Writing related field ) MS with a minimum of 8 years of related experience; PhD with a minimum of 6 years of related experience Tevas Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva&aposs global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva&aposs policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. Show more Show less