215 Biostatistics Jobs - Page 2

POSITION TITLE: Monitoring, Evaluation and Learning (MEL) Manager, EpiC India REPORTS TO: Team Leaders/Sr. Technical Advisor-HIV, EpiC India LOCATION: New Delhi, India DURATION: Till December 2025 (extendable subject to funding availability) About FHI 360 FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. FHI 360’s technical areas encompass a range of public health priorities, including HIV and AIDS; family planning and reproductive health; maternal and child health; health systems strengthening; integrated health and development; and infectious diseases, including tuberculosis and malaria, and more recently COVID-19 and Mpox. For more information, visit: https://www.fhi360.org . Background (EpiC Project) Meeting Targets and Achieving Epidemic Control (EpiC) is a global project funded by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) that provides strategic technical assistance and direct service delivery to achieve HIV epidemic control among at-risk populations and strengthen global health security. EpiC has been operational in India since 2021 and had been focusing on organizational capacity strengthening of community-based organizations (CBOs) working with vulnerable and at-risk populations in the states of Maharashtra and Telangana, and national level networks. Additionally, EpiC has been supporting lifesaving activities for people living with HIV (PLHIV) by addressing non-communicable disease (NCD) screening and management among adult/aging PLHIV clients; and enhancing engagement of young people living with HIV (YLHIV) for index testing and promotion of early initiation and retention on treatment, and responsible living through U=U messaging. In the light of the Executive Order issued by the Trump administration in January 2025, the EpiC India workplan for fiscal year 2025 is being revised to support implementation of lifesaving activities that align to the guidance issued by The Bureau of Global Health Security and Diplomacy (GHSD). In the PEPFAR supported geography of Maharashtra, EpiC is to: Accelerate early HIV case finding among hidden and unreached at-risk populations in community and facility settings to meet the 1st 95 goals. Support lifesaving care and treatment linkages through early linkage and retention on treatment, viral suppression to meet the 2nd and 3rd 95 goals. Address co-morbidities including mitigation of advanced HIV disease (AHD), tuberculosis (TB), opportunistic infections (OIs) and NCDs among adult PLHIV. Job Summary FHI 360 is seeking applications from qualified and experienced candidates to fill a new position of Monitoring, Evaluation and Learning (MEL) Manager for EpiC India. The incumbent is to be based at the FHI 360 Country Office in New Delhi and will be responsible for all strategic information (SI) responsibilities related to the project, including all monitoring, evaluation, analytics, reporting and documentation of performance and results. The MEL Manager will work closely with the project leadership, state and district level program and SI team members of EpiC and sub-grantee partners, to enhance or develop systems across sites and technical/thematic areas to support monitoring of service delivery and performance in real-time to improve service quality and impact and to meet reporting requirements. S/he will work across technical teams to provide consistent guidance and training on appropriate results frameworks and knowledge management practices for the project and its strategies. The MEL Manager will systematically strengthen the alignment of program strategies and activities to lessons learned from program data and client experiences. Job Responsibilities: Set-up / enhance the MEL and performance reporting system for the EpiC project, which will include working with the program team and sub-grantees to collect, analyze, monitor and report on performance of HIV services and activities. Develop tools and formats for data collection, analysis, interpretation and reporting in line with USAID’s latest MER indicators. Support the program team in defining the M&E roles of sub-grantees, reporting frequency, review mechanisms and set-up standardized monitoring mechanisms. Routinely support capacity building of EpiC and sub-grantee staff on M&E and ensure that the teams are oriented on the latest MER indicators and NACO/SACS M&E guidance and confidentiality norms. Review M&E data and reports from the field and ensure their accuracy and appropriateness by analyzing and interpreting the data, and support in data triangulation, visualization to track and monitor progress against targets. Facilitate routine quality checks and validation of sub-grantee/s data and provide feedback to the field staff based on the quality checks and validation exercise. Ensure adherence to quarterly data quality audits as required by donor/EpiC HQ. Ensure that supporting documentation is maintained for all data that is reported to FHI 360 HQ, USAID/PEPFAR, NACO, SACS and DAPCU and entered timely in DATIM. Support the EpiC program team in compilation of the monthly, quarterly and semi-annual progress reports and Plan of Action for Results Tracking (POART) slides and other ad hoc reporting requests. Liaise with relevant technical advisers and counterparts responsible for strategic information (SI) and M&E at EpiC HQ, and support coordination for country-level assistance as needed. Strengthen knowledge management deliverables for the project including documentation of case studies, success stories and other reports. Minimum Qualifications: Master’s degree or higher in epidemiology, M&E, demography, biostatistics, statistics, analytics, public health or other relevant discipline. Minimum 8 year experience on designing, establishing, and managing M&E systems, ensuring data quality, and analyzing data to support performance improvement of programs. Experience of working on M&E system for HIV programs is essential. Previous experience working with USAID or PEPFAR supported program is preferable. Demonstrated expertise in data analysis, managing online databases to ensure easy access to data and data reports, experience in Tableau or Power BI preferred. Demonstrated ability to perform complex data analytics utilizing Microsoft Excel, STATA, Epi Info; and/or software. Demonstrated ability to perform complex data analyses and make recommendations based on findings. Demonstrated working knowledge of the Indian health and social service information systems and M&E processes as it relates to data collection for performance-based reporting. Fluency in interpersonal, writing and oral presentation skills in English. The position will be based in New Delhi, India and work out of the FHI 360 Country office and is open for Indian national candidates only. This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time. Suitably qualified candidates openly living with HIV are also actively encouraged to apply. Compensation: Compensation levels at FHI 360 are equivalent to market rates within the development sector. However, offers shall be based on salary history, relevant experience, and qualifications. Please send your resumes to hrindia@fhi360.org. It is necessary to mention the post title in the subject line while applying. Only short-listed candidates will be notified. No calls/ emails will be entertained. This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time. FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law. Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks. FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws. FHI 360 will never ask you for your career site username or password, and we will never request money, goods or services during the application, recruitment or employment process. If you have questions or concerns about correspondence from us, please email CareerCenterSupport@fhi360.org . FHI 360 fosters the strength and health of its workforce through a competitive benefits package , professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

About EAII EAII Advisors, Evidence Action's technical partner in India, supports state governments in delivering evidence-based public health programs, including safe drinking water initiatives and school and Anganwadi-based National Deworming Day and iron and folic acid supplementation. Operating across 10 states, EAII Advisors provides technical assistance to ministries of health, education, water, and women and child development, reducing health burdens in impoverished communities and improving the long-term wellbeing of children and families. For more information, read about our work here: About Evidence Action and EAII About Evidence Action At Evidence Action, we deliver data-driven interventions that transform lives at an unprecedented scale. We identify neglected global health issues and deploy proven solutions, forging healthier futures for generations. Our model operationalizes leading academic research (including from Nobel-winning economists). We measure progress and outcomes at every stage to ensure we're making a real impact for people living in poverty and suffering from preventable or treatable health issues. Operating across 9 countries, our team of 800+ has reached over 500 million people, working closely with governments to scale these interventions. Our Deworm the World program has delivered over 2 billion treatments, significantly reducing worm prevalence and generating more than $23 billion in lifetime productivity gains. Through Safe Water Now, we've saved the lives of over 15,000 children. Our Accelerator explores untapped opportunities in global health, testing low-cost interventions with the greatest potential to save and improve lives. At Evidence Action, your colleagues are your greatest asset. You'll partner with high-caliber colleagues in an environment blending innovation, autonomy, and teamwork. Our team excels in disruptive thinking and believes in rolling up our sleeves to get things done. If you're looking to work flexibly and with purpose, join a team that delivers measurable change for millions. The Role The Manager- Monitoring, Learning & Evaluation (MLE) will be supporting the Safe Water Now program, reporting to the State Program Lead - with a dotted-line reporting to the Deputy Director. The role will primarily be responsible for assisting the national MLE team in the successful design, rollout of new initiatives and in the management of the MLE function in the state. The incumbent will be providing technical assistance to the state on situation analysis, preparing Monitoring, Learning & Evaluation (MLE) plans including design and measurable indicators (output and outcome) using SMART principles, data collection protocols, strategies for data use, reporting, strengthen monitoring systems, results-based management and support in dissemination of program findings. You will work closely with the state program team, MLE team at National Level, State Governments and partners to roll-out new initiatives and manage the process from design to roll-out. Responsibilities Technical Delivery Support in the development of MLE strategy, , frameworks, KPIs, and budgets for the Safe Water Now program, in collaboration with national and global teams Design and oversee research protocols, survey instruments, and methodologies for data collection, ensuring quality control, robust analysis, and effective dissemination of findings Lead the implementation of MLE activities, including surveys, secondary data sourcing, and internal monitoring, to drive decision-making and program improvements Strengthen monitoring and reporting systems, ensuring MLE-related KPIs are regularly met through robust tracking, web portals, dashboards, and follow-up mechanisms Analyze and visualize data, develop reports, and support the state team with data-driven insights and technical assistance for documentation and reporting Stay current with technical knowledge and guidelines (e.g., Jal Jeevan Mission) and build capacity of field teams on data quality, review, and analysis Identify opportunities for research publications, prepare articles and reports, and support peer-reviewed journal submissions Program Management Support in developing and managing partnerships, developing SOW, contracts and agreements for research and survey activities. Coordinate with program team (as required) for advocacy with state governments, to ensure that MLE activities and strategic initiatives are rolled-out as planned Manage partner and vendor relationships, ensuring budgets, expenditures, and deliverables align with program objectives Manage partner and vendor relationships relating to the new strategic initiatives, including development of budgets and costing, and monitoring actual expenditures Provide support in disseminating the findings of MLE initiatives, studies and other relevant data analysis Perform any other MLE related tasks and undertake other duties as required as necessary and assigned Attend meetings with donors, State level partners including State Government and other technical agencies and represent organization in meeting, conferences and other events Coordinating with the concerned Government officials to get updated and latest versions of all database (Contact number, MIS, etc) periodically. Team Management Manage the team of direct reportees to ensure timeliness and quality of the output Strengthen technical and team management capabilities of direct reportees and other team members Requirements Advance degree in statistics/biostatistics/population studies/economics/public health/ computer application or related field Must have 7 + years of work experience in MLE (ideally in the public sector) with a minimum of three years at managerial capacity with a solid understanding of MLE framework, theory of change, log frame etc Must have experience of developing and handling Public sector (Health/Water/WASH) IT applications and supply chain management Prior experience of developing MIS and/or technological platforms Strong analytical skills having experience in using advanced levels of MS-Excel is mandatory Willingness to travel as and when require (at least 20% of the time), often on short notice Experience in online data collection tools- ODK, Kobo collect and developing visualization reports and dashboards in Excel/Power BI/other software is preferred Experience in working with senior level government partners is desirable, with project management experience working with state governments to implement large projects Prior experience with mobile or CAPI based surveys are highly preferred Knowledge of Stata or any other Statistical packages (SPSS etc.) is desirable Benefits EAII provides a comprehensive benefits package for employees worldwide. Benefits include: comprehensive health insurance, retirement savings options, life insurance, generous leave, avenues for engagement and recognition Compensation: Competitive and commensurate with the individual's credentials, experience, and previous pay scale. All contracting arrangements will be made through EAII Advisors Private Limited. EAII is an equal opportunity employer. Employment at EAII is based solely on an individual's merit and qualifications directly related to professional competence. EAII does not discriminate against any employee or applicant because of race, caste, creed, colour, religion, gender, origin, disability, marital status, or any other basis protected by law. All candidates applying for the position should upload a resume and provide information around current and expected salary. Show more Show less

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based SAS Programmer to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities Write SAS programs for use in creating analysis datasets, tables, listings, and figures Using SAS, program, validate and maintain mapped database Program edit checks for external data Coordinate communication and issues with Data Management regarding database specifications and data transfers Qualifications Bachelor / Master’s Degree in math, Statistics, health informatics, data science, computer science, or life sciences field SAS Ceritifcation SAS knowledge required and 1 to 2 years' experience is preferred Good English written/communication skills is required Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. Show more Show less

POSITION TITLE: Monitoring, Evaluation and Learning (MEL) Manager, EpiC India REPORTS TO: Team Leaders/Sr. Technical Advisor-HIV, EpiC India LOCATION: New Delhi, India DURATION: Till December 2025 (extendable subject to funding availability) About FHI 360 FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. FHI 360’s technical areas encompass a range of public health priorities, including HIV and AIDS; family planning and reproductive health; maternal and child health; health systems strengthening; integrated health and development; and infectious diseases, including tuberculosis and malaria, and more recently COVID-19 and Mpox. For more information, visit: https://www.fhi360.org. Background (EpiC Project) Meeting Targets and Achieving Epidemic Control (EpiC) is a global project funded by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) that provides strategic technical assistance and direct service delivery to achieve HIV epidemic control among at-risk populations and strengthen global health security. EpiC has been operational in India since 2021 and had been focusing on organizational capacity strengthening of community-based organizations (CBOs) working with vulnerable and at-risk populations in the states of Maharashtra and Telangana, and national level networks. Additionally, EpiC has been supporting lifesaving activities for people living with HIV (PLHIV) by addressing non-communicable disease (NCD) screening and management among adult/aging PLHIV clients; and enhancing engagement of young people living with HIV (YLHIV) for index testing and promotion of early initiation and retention on treatment, and responsible living through U=U messaging. In the light of the Executive Order issued by the Trump administration in January 2025, the EpiC India workplan for fiscal year 2025 is being revised to support implementation of lifesaving activities that align to the guidance issued by The Bureau of Global Health Security and Diplomacy (GHSD). In the PEPFAR supported geography of Maharashtra, EpiC is to: Accelerate early HIV case finding among hidden and unreached at-risk populations in community and facility settings to meet the 1st 95 goals. Support lifesaving care and treatment linkages through early linkage and retention on treatment, viral suppression to meet the 2nd and 3rd 95 goals. Address co-morbidities including mitigation of advanced HIV disease (AHD), tuberculosis (TB), opportunistic infections (OIs) and NCDs among adult PLHIV. Job Summary FHI 360 is seeking applications from qualified and experienced candidates to fill a new position of Monitoring, Evaluation and Learning (MEL) Manager for EpiC India. The incumbent is to be based at the FHI 360 Country Office in New Delhi and will be responsible for all strategic information (SI) responsibilities related to the project, including all monitoring, evaluation, analytics, reporting and documentation of performance and results. The MEL Manager will work closely with the project leadership, state and district level program and SI team members of EpiC and sub-grantee partners, to enhance or develop systems across sites and technical/thematic areas to support monitoring of service delivery and performance in real-time to improve service quality and impact and to meet reporting requirements. S/he will work across technical teams to provide consistent guidance and training on appropriate results frameworks and knowledge management practices for the project and its strategies. The MEL Manager will systematically strengthen the alignment of program strategies and activities to lessons learned from program data and client experiences. Job Responsibilities: Set-up / enhance the MEL and performance reporting system for the EpiC project, which will include working with the program team and sub-grantees to collect, analyze, monitor and report on performance of HIV services and activities. Develop tools and formats for data collection, analysis, interpretation and reporting in line with USAID’s latest MER indicators. Support the program team in defining the M&E roles of sub-grantees, reporting frequency, review mechanisms and set-up standardized monitoring mechanisms. Routinely support capacity building of EpiC and sub-grantee staff on M&E and ensure that the teams are oriented on the latest MER indicators and NACO/SACS M&E guidance and confidentiality norms. Review M&E data and reports from the field and ensure their accuracy and appropriateness by analyzing and interpreting the data, and support in data triangulation, visualization to track and monitor progress against targets. Facilitate routine quality checks and validation of sub-grantee/s data and provide feedback to the field staff based on the quality checks and validation exercise. Ensure adherence to quarterly data quality audits as required by donor/EpiC HQ. Ensure that supporting documentation is maintained for all data that is reported to FHI 360 HQ, USAID/PEPFAR, NACO, SACS and DAPCU and entered timely in DATIM. Support the EpiC program team in compilation of the monthly, quarterly and semi-annual progress reports and Plan of Action for Results Tracking (POART) slides and other ad hoc reporting requests. Liaise with relevant technical advisers and counterparts responsible for strategic information (SI) and M&E at EpiC HQ, and support coordination for country-level assistance as needed. Strengthen knowledge management deliverables for the project including documentation of case studies, success stories and other reports. Minimum Qualifications: Master’s degree or higher in epidemiology, M&E, demography, biostatistics, statistics, analytics, public health or other relevant discipline. Minimum 8 year experience on designing, establishing, and managing M&E systems, ensuring data quality, and analyzing data to support performance improvement of programs. Experience of working on M&E system for HIV programs is essential. Previous experience working with USAID or PEPFAR supported program is preferable. Demonstrated expertise in data analysis, managing online databases to ensure easy access to data and data reports, experience in Tableau or Power BI preferred. Demonstrated ability to perform complex data analytics utilizing Microsoft Excel, STATA, Epi Info; and/or software. Demonstrated ability to perform complex data analyses and make recommendations based on findings. Demonstrated working knowledge of the Indian health and social service information systems and M&E processes as it relates to data collection for performance-based reporting. Fluency in interpersonal, writing and oral presentation skills in English. The position will be based in New Delhi, India and work out of the FHI 360 Country office and is open for Indian national candidates only. This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time. Suitably qualified candidates openly living with HIV are also actively encouraged to apply. Compensation: Compensation levels at FHI 360 are equivalent to market rates within the development sector. However, offers shall be based on salary history, relevant experience, and qualifications. Please send your resumes to hrindia@fhi360.org. It is necessary to mention the post title in the subject line while applying. Only short-listed candidates will be notified. No calls/ emails will be entertained. This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time. FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law. Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks. FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws. FHI 360 will never ask you for your career site username or password, and we will never request money, goods or services during the application, recruitment or employment process. If you have questions or concerns about correspondence from us, please email CareerCenterSupport@fhi360.org. FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself. Please click here to continue searching FHI 360's Career Portal. Show more Show less

POSITION TITLE: Monitoring, Evaluation and Learning (MEL) Manager, EpiC India REPORTS TO: Team Leaders/Sr. Technical Advisor-HIV, EpiC India LOCATION: New Delhi, India DURATION: Till December 2025 (extendable subject to funding availability) About FHI 360 FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. FHI 360’s technical areas encompass a range of public health priorities, including HIV and AIDS; family planning and reproductive health; maternal and child health; health systems strengthening; integrated health and development; and infectious diseases, including tuberculosis and malaria, and more recently COVID-19 and Mpox. For more information, visit: https://www.fhi360.org . Background (EpiC Project) Meeting Targets and Achieving Epidemic Control (EpiC) is a global project funded by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) that provides strategic technical assistance and direct service delivery to achieve HIV epidemic control among at-risk populations and strengthen global health security. EpiC has been operational in India since 2021 and had been focusing on organizational capacity strengthening of community-based organizations (CBOs) working with vulnerable and at-risk populations in the states of Maharashtra and Telangana, and national level networks. Additionally, EpiC has been supporting lifesaving activities for people living with HIV (PLHIV) by addressing non-communicable disease (NCD) screening and management among adult/aging PLHIV clients; and enhancing engagement of young people living with HIV (YLHIV) for index testing and promotion of early initiation and retention on treatment, and responsible living through U=U messaging. In the light of the Executive Order issued by the Trump administration in January 2025, the EpiC India workplan for fiscal year 2025 is being revised to support implementation of lifesaving activities that align to the guidance issued by The Bureau of Global Health Security and Diplomacy (GHSD). In the PEPFAR supported geography of Maharashtra, EpiC is to: Accelerate early HIV case finding among hidden and unreached at-risk populations in community and facility settings to meet the 1st 95 goals. Support lifesaving care and treatment linkages through early linkage and retention on treatment, viral suppression to meet the 2nd and 3rd 95 goals. Address co-morbidities including mitigation of advanced HIV disease (AHD), tuberculosis (TB), opportunistic infections (OIs) and NCDs among adult PLHIV. Job Summary FHI 360 is seeking applications from qualified and experienced candidates to fill a new position of Monitoring, Evaluation and Learning (MEL) Manager for EpiC India. The incumbent is to be based at the FHI 360 Country Office in New Delhi and will be responsible for all strategic information (SI) responsibilities related to the project, including all monitoring, evaluation, analytics, reporting and documentation of performance and results. The MEL Manager will work closely with the project leadership, state and district level program and SI team members of EpiC and sub-grantee partners, to enhance or develop systems across sites and technical/thematic areas to support monitoring of service delivery and performance in real-time to improve service quality and impact and to meet reporting requirements. S/he will work across technical teams to provide consistent guidance and training on appropriate results frameworks and knowledge management practices for the project and its strategies. The MEL Manager will systematically strengthen the alignment of program strategies and activities to lessons learned from program data and client experiences. Job Responsibilities: Set-up / enhance the MEL and performance reporting system for the EpiC project, which will include working with the program team and sub-grantees to collect, analyze, monitor and report on performance of HIV services and activities. Develop tools and formats for data collection, analysis, interpretation and reporting in line with USAID’s latest MER indicators. Support the program team in defining the M&E roles of sub-grantees, reporting frequency, review mechanisms and set-up standardized monitoring mechanisms. Routinely support capacity building of EpiC and sub-grantee staff on M&E and ensure that the teams are oriented on the latest MER indicators and NACO/SACS M&E guidance and confidentiality norms. Review M&E data and reports from the field and ensure their accuracy and appropriateness by analyzing and interpreting the data, and support in data triangulation, visualization to track and monitor progress against targets. Facilitate routine quality checks and validation of sub-grantee/s data and provide feedback to the field staff based on the quality checks and validation exercise. Ensure adherence to quarterly data quality audits as required by donor/EpiC HQ. Ensure that supporting documentation is maintained for all data that is reported to FHI 360 HQ, USAID/PEPFAR, NACO, SACS and DAPCU and entered timely in DATIM. Support the EpiC program team in compilation of the monthly, quarterly and semi-annual progress reports and Plan of Action for Results Tracking (POART) slides and other ad hoc reporting requests. Liaise with relevant technical advisers and counterparts responsible for strategic information (SI) and M&E at EpiC HQ, and support coordination for country-level assistance as needed. Strengthen knowledge management deliverables for the project including documentation of case studies, success stories and other reports. Minimum Qualifications: Master’s degree or higher in epidemiology, M&E, demography, biostatistics, statistics, analytics, public health or other relevant discipline. Minimum 8 year experience on designing, establishing, and managing M&E systems, ensuring data quality, and analyzing data to support performance improvement of programs. Experience of working on M&E system for HIV programs is essential. Previous experience working with USAID or PEPFAR supported program is preferable. Demonstrated expertise in data analysis, managing online databases to ensure easy access to data and data reports, experience in Tableau or Power BI preferred. Demonstrated ability to perform complex data analytics utilizing Microsoft Excel, STATA, Epi Info; and/or software. Demonstrated ability to perform complex data analyses and make recommendations based on findings. Demonstrated working knowledge of the Indian health and social service information systems and M&E processes as it relates to data collection for performance-based reporting. Fluency in interpersonal, writing and oral presentation skills in English. The position will be based in New Delhi, India and work out of the FHI 360 Country office and is open for Indian national candidates only. This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time. Suitably qualified candidates openly living with HIV are also actively encouraged to apply. Compensation: Compensation levels at FHI 360 are equivalent to market rates within the development sector. However, offers shall be based on salary history, relevant experience, and qualifications. Please send your resumes to hrindia@fhi360.org. It is necessary to mention the post title in the subject line while applying. Only short-listed candidates will be notified. No calls/ emails will be entertained. This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time. FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law. Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks. FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws. FHI 360 will never ask you for your career site username or password, and we will never request money, goods or services during the application, recruitment or employment process. If you have questions or concerns about correspondence from us, please email CareerCenterSupport@fhi360.org . FHI 360 fosters the strength and health of its workforce through a competitive benefits package , professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

Overview 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. 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. Qualifications And Prerequisites 1-3 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. Show more Show less

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). Show more Show less

Design statistical analysis plans for clinical trialsobservational studiesand laboratory experiments. Perform statistical analyses using appropriate software (egSASRPython). Collaborate with clinical researchersdata managersand regulatory teams to ensure data integrity and compliance. Interpret and communicate statistical results clearly to cross-functional teams and stakeholders. Prepare tableslistingsand figures for clinical study reports and publications. Support the preparation of documents for regulatory submissions (egFDAEMA). Stay current with advancements in biostatistics and relevant regulatory guidelines. Contribute to protocol developmentdata monitoringand interim analysis. Provide statistical consulting to internal teams on study design and methodology.

Premier Research is looking for a Principal Biostatistical Programmer to join our Biostatistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. This role will be specifically working in our end-to-end team therefore SDTM, ADaM and TLF experience is required. What You'll Be Doing Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells Performs quality control (source code review, double-programming and log review) of SAS programs Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications Prepares specifications for CDISC and other analysis data sets Assists Data Management with SAS programming needs Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team Develops and validates general SAS macros What We Are Searching For BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms. Show more Show less

Job Title: Clinical Data Analyst Department: Data Management and Statistics Reports To: Associate Director, Biostatistics and Analytics Location: Remote Employment Type: Full-Time Job Summary: The Clinical Data Analyst will play a key role in generating actionable insights through advanced data analysis and reporting. This position requires strong expertise in R programming, data visualisation, and automation to support informed decision-making across teams. The role contributes directly to enhancing the consistency, efficiency, and quality of data reporting within a clinical research or healthcare environment. Key Responsibilities: Develop and maintain automated reports and dashboards using R programming to support various stakeholders. Standardize reporting tools and templates to ensure consistent presentation of clinical and operational data. Create visualisations and conduct trend analyses to identify performance patterns and study-related insights. Collaborate with cross-functional teams to gather requirements and deliver tailored analytical solutions. Provide analytical support for forecasting, resource planning, and study metrics such as FTE and SDV. Maintain thorough documentation of data processes, methods, and reporting protocols. Monitor tool performance, identify bugs or inconsistencies, and coordinate resolution with relevant teams. Support updates to SOPs, work instructions, and programming standards to align with current best practices. Ensure adherence to applicable data protection regulations, quality standards, and internal policies. Key Performance Indicators (KPIs): Timely and accurate delivery of reports and analytical tools Stakeholder satisfaction and engagement Percentage of automated reporting processes Quality and accuracy of data-driven projections Number of bugs/issues resolved Compliance with audit requirements and data standards Volume of self-initiated or support-driven projects Participation in training or knowledge-sharing initiatives Required Qualifications: Education: Bachelor’s degree in Statistics, Biostatistics, Mathematics, or a related quantitative field. Experience: 4–6 years of relevant experience in data analysis, ideally within a clinical research or healthcare setting. Technical Skills: Advanced R programming and data manipulation Automation and reporting tool development Data visualisation and interpretation Documentation and protocol writing Basic project management Behavioural Competencies: Strong communication and collaboration abilities Detail-oriented with analytical thinking Effective problem-solving skills Time management and ability to handle multiple priorities Show more Show less

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: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description Position Summary: The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards. The position requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams in accordance with departmental processes and procedures. As a highly experienced Principal Programming Lead, they apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to other programmers. The Principal Programming Lead position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality. In this role, the Principal Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams. In addition, this position may lead and contribute expert knowledge and technical skills to assigned delivery unit, departmental innovation, and process improvement projects. Principal Responsibilities Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests. Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes. Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed. Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities. Performs comprehensive review of, and provides input into, project requirements and documentation. Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations. 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. Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads. Contributes to and may lead departmental innovation and process improvement projects and may contribute programming expertise to cross functional projects/initiatives. May play the role of a Delivery Unit/Disease Area Expert. Ensures continued compliance of project/programs and required company and departmental training, time reporting, and other business/operational processes as required for position. Clinical Programming Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards. Responsible for implementation of data tabulation standards. Performs data cleaning by programming edit checks and data review listings and Data reporting by creating data visualizations and listings for medical monitoring and central monitoring. Statistical Programming Responsible for implementation of data and analysis standards ensuring consistency in analysis dataset design across trials within a program. Principal Relationships The Principal Programming Lead 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 (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g., Master, PhD). Experience And Skills Required Approx. 12+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. In-depth knowledge of programming practices (including tools and processes). Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11) Project, risk, and team management and an established track record leading teams to successful outcomes. Excellent planning and coordination of project delivery. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors. Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments. Experience managing the outsourcing or externalization of programming activities in the clinical trials setting (e.g., Working with CROs, academic institutions) preferred experience. Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (e.g., working with CROs, academic institutions) is preferred. Expert CDISC Standards knowledge. Expert knowledge of relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required for a Clinical Programming role. Excellent written and verbal communications and influencing and negotiation skills. Advanced knowledge of programming and industry standard data structures, thorough understanding of end-to-end clinical trial process and relevant clinical research concepts. Other Innovative thinking allows for optimal design and execution of programming development strategies. Development and implementation of a business change/innovative way of working. Show more Show less

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. 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 People Leader All Job Posting Locations: Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India Job Description Integrated Data Analytics and Reporting (IDAR) Associate Director Portfolio Lead Clinical Programming* (*Title may vary based on Region or Country requirements) Position Summary The Associate Director Portfolio Lead Clinical Programming is a highly experienced individual with expert understanding of programming strategies, practices, methods, processes, technologies, industry standards, complex data structures, and analysis and reporting solutions. This position requires strong project and people leadership skills with the capability to effectively coordinate and oversee programming activities across teams in accordance with company and departmental processes and procedures. As a portfolio leader, this position is responsible for formulating the Programming strategy across a large portfolio of one or more programs within a Disease area and/or Delivery Unit, with accountability for operational oversight and effective planning and execution of programming activities for their assigned portfolio. This position interfaces with program level Delivery Unit Leaders to provide regular status updates, identify and manage risks and issues, and ensures the appropriate use of escalation pathways to appropriate functional leaders as needed. This position provides functional area people and/or matrix leadership to departmental staff. The role is responsible for the recruitment, onboarding, performance management and development of people and future skills and technical knowledge expertise within their reporting line while building an inclusive and diverse working environment. The Associate Director Portfolio Lead Clinical Programming may also take on responsibilities of second line management (i.e. manager of managers). The Associate Director Portfolio Lead Clinical Programming role plays a critical role in the growth and development of C&SP and contributes to organizational effectiveness, transparency, and communication. Directly contributes to delivery of the J&J IM R&D portfolio through effective leadership and accountability of large or complex clinical development and strategic innovation of programs and projects. In collaboration with Senior departmental leadership, the Senior Manager Portfolio Lead influences departmental effectiveness acting as a change agent to shape, drive and implement the departmental strategic vision. This position develops strong and productive working relationships with key stakeholders within IDAR in addition to broader partners, external suppliers and/or industry groups. Principal Responsibilities As Project Leader: Drives the strategy and planning, execution, and completion of all programming activities and deliverables within assigned scope ensuring quality, compliance standards, consistency, and efficiency. Proactively evaluates and manage resource demand, allocation, utilization, and delivery to meet current and future business needs. Ensure timely and effective maintenance of functional planning systems. May include forecasting related to potential in-licensing and acquisitions. Independently and effectively manages issue escalations, adopting appropriate escalation pathways. Collaborates with cross-functional and external partners on programming related deliverables for co-development programs and defining data integration strategy of the assigned programs/projects. Ensures training compliance and development of appropriate job skills for assigned personnel. Contributes to the development of functional vendor contracts and oversees of delivery in line with agreed milestones and scope of work, R&D business planning and budget estimates. Serves as the primary point of contact for sourcing providers and is responsible for establishing a strategic partnership. Drives the enhancement of functional, technical and/or scientific capabilities within C&SP and shares best practices. Leads programming related aspects of regulatory agency inspections and J&J internal audits ensuring real time inspection readiness for all programming deliverables. Provides input to submission strategy to regulatory agencies and ensures all programming deliverables are complete and compliant. As People Leader Responsible for attracting and retaining top talent, proactively managing performance, and actively supporting talent development and succession planning. Ensures organizational effectiveness, transparency, and communication. Provides mentorship and coaching to programming team members. Ensures training compliance and development of appropriate job skills for assigned personnel. Oversees their work allocation, providing coaching and guidance as necessary. Responsible for local administration and decision making associated with the management of assigned personnel. As Matrix Leader Accountable for actively identifying opportunities, evaluating, and driving solutions to enhance efficiency and knowledge-sharing across programs, value streams and the department. Serves as departmental resource in areas of process and technical expertise. Stays current with industry trends and policies related to Programming. Leads departmental innovation and process improvement projects and as required, may contribute programming expertise to cross functional projects/initiatives. Provides strategic direction within Delivery Unit initiatives and projects. Serves as a programming expert and influencer on internal and external (industry) work groups. Clinical Programming Leader Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards. Statistical Programming Leader Responsible for implementation of data and analysis standards ensuring consistency in analysis dataset design across trials within a program. Principal Relationships This role reports into a people manager position within the Delivery unit and is accountable to the Director of Programming 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 (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g., Master, PhD). Experience And Skills Required Approx. 15+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. In-depth knowledge of programming practices (including tools and processes). In depth knowledge of regulatory guidelines (e.g., ICH-GCP). Project, risk, and team management and an established track record leading teams to successful outcomes. Excellent people management skills including staff performance management and people development. Excellent planning and coordinating of deliverables. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors. Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments. Excellent written and verbal communications skills. Demonstrated experience managing the outsourcing or externalization programming activities in the clinical trials setting (e.g. working with CROs, academic institutions) is preferred. Expert CDISC Standards knowledge. Expert knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Other Innovative thinking to allow for optimal design and execution of clinical and/or statistical development strategies. Development and implementation of a business change/innovative way of working. Show more Show less

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. 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: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description Principal Responsibilities: Completes programming trial activities of low complexity and/or criticality, with high quality and timeliness of deliverables. Designs and develops programs in support of clinical analysis and reporting activities. May support submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages. Performs activities in accordance with departmental processes and procedures. Performs appropriate quality control and verification in support of clinical analyses and reporting activities. Performs review and provides feedback on project requirements and documentation. Collaborates effectively with team and cross-functional members. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Clinical Programmer Reviews specifications for mapping internal Data Review Model (DRM) for fit-for-purpose reporting consumption and ensures verification of DRM. 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 and Study Leads 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, 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/data engineering/analytics, public health, or other relevant scientific field (or equivalent theoretical/technical depth). Experience And Skills Required Basic knowledge of data structures and relevant programming languages for data manipulation, and statistical reporting which may include SAS, R, Python etc. Knowledge of SAS is preferred for Clinical Programming role. Basic knowledge of processes, methods, and concepts relevant to programming. Experience working in a team environment preferred. Demonstrated written and verbal communication skills. Show more Show less

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: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description Position Summary: The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards. The position requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams in accordance with departmental processes and procedures. As a highly experienced Principal Programming Lead, they apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to other programmers. The Principal Programming Lead position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality. In this role, the Principal Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams. In addition, this position may lead and contribute expert knowledge and technical skills to assigned delivery unit, departmental innovation, and process improvement projects. Principal Responsibilities Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests. Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes. Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed. Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities. Performs comprehensive review of, and provides input into, project requirements and documentation. Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations. 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. Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads. Contributes to and may lead departmental innovation and process improvement projects and may contribute programming expertise to cross functional projects/initiatives. May play the role of a Delivery Unit/Disease Area Expert. Ensures continued compliance of project/programs and required company and departmental training, time reporting, and other business/operational processes as required for position. Clinical Programming Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards. Responsible for implementation of data tabulation standards. Performs data cleaning by programming edit checks and data review listings and Data reporting by creating data visualizations and listings for medical monitoring and central monitoring. Statistical Programming Responsible for implementation of data and analysis standards ensuring consistency in analysis dataset design across trials within a program. Principal Relationships The Principal Programming Lead 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 (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g., Master, PhD). Experience And Skills Required Approx. 12+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. In-depth knowledge of programming practices (including tools and processes). Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11) Project, risk, and team management and an established track record leading teams to successful outcomes. Excellent planning and coordination of project delivery. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors. Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments. Experience managing the outsourcing or externalization of programming activities in the clinical trials setting (e.g., Working with CROs, academic institutions) preferred experience. Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (e.g., working with CROs, academic institutions) is preferred. Expert CDISC Standards knowledge. Expert knowledge of relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required for a Clinical Programming role. Excellent written and verbal communications and influencing and negotiation skills. Advanced knowledge of programming and industry standard data structures, thorough understanding of end-to-end clinical trial process and relevant clinical research concepts. Other Innovative thinking allows for optimal design and execution of programming development strategies. Development and implementation of a business change/innovative way of working. Show more Show less

Job Description Associate Director, Data Engineering Based in Hyderabad, join a global healthcare biopharma company and be part of a 130-year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Led an Organization driven by digital technology and data-backed approaches that supports a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be the leaders who have a passion for using data, analytics, and insights to drive decision-making, which will allow us to tackle some of the world's greatest health threats. Our Technology centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. AN integral part of the our company's IT operating model, Tech centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each tech center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers. Role Overview As the Associate Director, Data Engineering, your role will focus on business intelligence at the organization to enhance data-driven decision-making across the organization. This role is crucial for transforming data into valuable insights that drive business performance, support strategic initiatives and ultimately contribute to our company's mission to use science to improve and save lives around the world. What Will You Do In This Role You will develop and ensure that business intelligence activities are efficient and effective, enabling timely access to accurate data for informed decision-making, and focused on automation, controls, and data quality. Design, develop and maintain data pipelines to extract data from a variety of sources and populate data lake and data warehouse. Collaborate with Data Analyst, Data scientists, Machine Learning Engineers to identify and transform data for ingestion, exploration, and modeling. Work with data governance team and implement data quality checks and maintain data catalogs. Use Orchestration, logging, and monitoring tools to build resilient pipelines. Use test driven development methodology when building ELT/ETL pipelines. Understand and apply concepts like data lake, data warehouse, lake-house, data mesh and data-fabric where relevant. Develop data models for cloud data warehouses like Redshift and Snowflake. Develop pipelines to ingest data into cloud data warehouses. You will investigate enterprise data requirements where there is some complexity and ambiguity and plan own data modeling and design activities, selecting appropriate techniques and the correct level of detail for meeting assigned objectives. You will define and implement data engineering strategies that align with organizational goals and data governance standards. You will play a lead role in agile engineering and consulting, providing guidance on for complex data and unplanned data challenges. You will collaborate in the formulation of analytics policies, standards, and best practices to ensure consistency and compliance across the organization. Encourages a culture of continuous learning, constructive collaboration, and innovation within the team. What Should You Have Bachelor's degree in Computer Science/Engineering, Data Sciences, Bioinformatics, Biostatistics or any other computational quantitative science. Minimum of 5-7 years of developing data pipelines & data infrastructure, ideally within a drug development or life sciences context. Expert in software / data engineering practices (including versioning, release management, deployment of datasets, agile & related software tools). Strong software development skills in R and Python, SQL, PySpark. Agile working knowledge. Strong working knowledge of at least one large-scale data processing technology (e.g. High-performance computing, distributed computing), databases and underlying technology (cloud or on-prem environments, containerization, distributed storage & databases). Strong interpersonal and communication skills (verbal and written) effectively bridging scientific and business needs; experience working in a matrix environment. Proven record of delivering high-quality results in quantitative sciences and/or a solid publication track record. Our technology teams operate as business partners, proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver services and solutions that help everyone be more productive and enable innovation. Who we are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Business Intelligence (BI), Database Administration, Data Engineering, Data Management, Data Modeling, Data Visualization, Design Applications, Information Management, Software Development, Software Development Life Cycle (SDLC), System Designs Preferred Skills Job Posting End Date 07/14/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R336586 Show more Show less

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: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description Principal Responsibilities: Completes programming trial activities of low complexity and/or criticality, with high quality and timeliness of deliverables. Designs and develops programs in support of clinical analysis and reporting activities. May support submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages. Performs activities in accordance with departmental processes and procedures. Performs appropriate quality control and verification in support of clinical analyses and reporting activities. Performs review and provides feedback on project requirements and documentation. Collaborates effectively with team and cross-functional members. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Clinical Programmer Reviews specifications for mapping internal Data Review Model (DRM) for fit-for-purpose reporting consumption and ensures verification of DRM. 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 and Study Leads 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, 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/data engineering/analytics, public health, or other relevant scientific field (or equivalent theoretical/technical depth). Experience And Skills Required Basic knowledge of data structures and relevant programming languages for data manipulation, and statistical reporting which may include SAS, R, Python etc. Knowledge of SAS is preferred for Clinical Programming role. Basic knowledge of processes, methods, and concepts relevant to programming. Experience working in a team environment preferred. Demonstrated written and verbal communication skills. Show more Show less

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: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description Principal Responsibilities: Completes programming trial activities of low complexity and/or criticality, with high quality and timeliness of deliverables. Designs and develops programs in support of clinical analysis and reporting activities. May support submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages. Performs activities in accordance with departmental processes and procedures. Performs appropriate quality control and verification in support of clinical analyses and reporting activities. Performs review and provides feedback on project requirements and documentation. Collaborates effectively with team and cross-functional members. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Clinical Programmer Reviews specifications for mapping internal Data Review Model (DRM) for fit-for-purpose reporting consumption and ensures verification of DRM. 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 and Study Leads 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, 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/data engineering/analytics, public health, or other relevant scientific field (or equivalent theoretical/technical depth). Experience And Skills Required Basic knowledge of data structures and relevant programming languages for data manipulation, and statistical reporting which may include SAS, R, Python etc. Knowledge of SAS is preferred for Clinical Programming role. Basic knowledge of processes, methods, and concepts relevant to programming. Experience working in a team environment preferred. Demonstrated written and verbal communication skills. Show more Show less

To use advanced data analysis for providing actionable insights that support data-driven decision-making within teams by utilizing R programming language, developing automation tools for oversight and standardized reporting templates to enhance the efficiency and consistency of information across the organization. Role & responsibilities Data Analytics and Reporting Design and develop detailed reports leveraging various databases, using R language to generate meaningful insights. Proactively develop automation tools, standardized reporting tools & templates (including slides) for use by stakeholders to enable consistent presentation of information across the teams. Create visualizations and trend analysis to identify patterns in study performance or other relevant areas. Monitor and document any bugs or issues related to the reporting tools and work with the concerned teams for timely resolution. Stakeholder Collaboration Collaborate with cross-functional teams proactively to gather and understand reporting requirements, translating them into programming Specifications. Assist leadership teams in data-driven decision making by providing actionable insights such as budget projections, resource allocation, Full Time Equivalent (FTE) predictions etc. through various reports. Act as the bridge between data teams and other departments, gathering requirements and output Specifications for new analytical tools or reports. Utilize data to perform analytics, thereby predicting future requirements, provide real-time analysis of study quality metrics, site performance metrics and generate reports for Source Data Verification (SDV). Analytics Project Management Maintain clear documentation of methodologies, data processes, and report-generation protocols to ensure transparency and reproducibility of analyses. Assist in the development of performance metrics based on communicated requirements, contributing to the overall efficiency and effectiveness of clinical operations. Develop clear and concise communication around project progress, key findings, and recommendations to various stakeholders. Keep track of the number of projects progress and provide regular reports to Associate Director, Biostatistics and Analytics. Policies, Processes & Procedures Conduct day to day activities & follow all relevant policies, processes, standard operating procedures and instructions so that work is carried out in a controlled and consistent manner. Assist in the updating departmental and role Specific programming standards, Standard Operating Procedures (SOPs), Working Procedural Documents (WPDs), and templates to reflect current practices and regulatory requirements. Implement new initiatives/ projects as per established policies to meet future requirements of the function. Comply with the company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection Key interactions Clinical operations Biostatisticians Clinical Informatics Clinical Data Management Project Management Functional / Behavioral Skills required to execute the role R Programming Automation and Tool Development Data Analysis and Interpretation Documentation and Reporting Project Management Communication Detail orientation Problem solving Time management Hands on experience in data analysis, preferably within a clinical research or healthcare setting

Hello Candidate , We are #hiring for Project Associate - I ! Government Project Payroll company: - E Solutions Job role: - Project Associate - I ! Educational Qualifications: Masters degree in Statistics / Biostatistics from recognized University / Institution with one year of experience. No. of Vacancy :- 01 Age Limit: The upper age limit is 40 years

Key Responsibilities Design statistical analysis plans for clinical trialsobservational studiesand laboratory experiments. Perform statistical analyses using appropriate software (e.g.SASRPython). Collaborate with clinical researchersdata managersand regulatory teams to ensure data integrity and compliance. Interpret and communicate statistical results clearly to cross-functional teams and stakeholders. Prepare tableslistingsand figures for clinical study reports and publications. Support the preparation of documents for regulatory submissions (e.g.FDAEMA). Stay current with advancements in biostatistics and relevant regulatory guidelines. Contribute to protocol developmentdata monitoringand interim analysis. Provide statistical consulting to internal teams on study design and methodology.

Description Medical Writer I Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision. Develops or supports, a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinicalstudy reports; o Patient narratives; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills. Is aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications 1. Any Life Science postgraduate-Prefer M.Pharm,PharmD 2. Candidates having experience in Clinical Trial Disclosure, Regulatory Medical Writing, Pharmacovigilance (Safety Narrative Writing). 3. Responsibilities include drafting CTD documents for clients and performing quality checks (QC) documents 4. Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EUCTR 0. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Job Title: Statistics Specialist – Clinical Support Department: Clinical Affairs / Data Analytics Location: SS Innovations Pvt. Ltd., Gurugram, India Experience Required: 3–5 Years Reporting To: Team Leader – Clinical Support Data Analysis / Clinical Affairs Manager Job Summary: The Statistics Specialist – Clinical Support is responsible for managing and analyzing clinical and operational data related to surgical robotic systems. The role requires strong statistical acumen to support clinical trials, post-market surveillance, research studies, and evidence generation initiatives. This position plays a key role in transforming complex data into meaningful insights to aid clinical decision-making and regulatory submissions. Key Responsibilities: Perform statistical analysis of clinical study data, observational studies, and retrospective reviews related to SS Innovations’ surgical robotic systems. Provide statistical input for clinical study design, sample size calculations, and protocol development. Support data management activities including cleaning, validation, and review of clinical data for accuracy and consistency. Prepare statistical analysis plans (SAP), summary tables, figures, listings, and final study reports. Collaborate with clinical, R&D, and regulatory teams to generate data-driven evidence to support safety, efficacy, and usability claims. Work with biostatistical software such as SAS, R, or SPSS to conduct exploratory and confirmatory data analysis. Contribute to scientific publications, abstracts, posters, and conference materials. Assist in preparation of data for regulatory submissions (e.g., US FDA, CE Marking, CDSCO, etc.). Monitor data trends to identify early signals, adverse events, or areas requiring further investigation. Ensure compliance with ICH-GCP, ISO 14155, and other applicable statistical and clinical research standards. Requirements: Master’s degree in Statistics, Biostatistics, Mathematics, Epidemiology, or a related field. 3–5 years of experience in a clinical or medical device/statistics role. Strong knowledge of clinical trial methodology, design, and statistical principles. Proficiency in statistical software (SAS, R, SPSS, or equivalent). Experience working with large datasets and clinical databases (EDC, CRFs, etc.). Excellent analytical, problem-solving, and documentation skills. Strong communication skills and ability to work in a cross-functional, fast-paced environment. Familiarity with global regulatory requirements and standards for medical devices is preferred. Preferred Skills: Prior experience in a MedTech or surgical robotics company. Exposure to clinical study submissions to US FDA, CE, or other regulatory bodies. Understanding of AI-assisted data models and predictive analytics in healthcare. Show more Show less

Summary The Principal Real World Evidence (RWE) Research Analyst is responsible for the scientific and methodological aspects of all RWE projects as well as providing guidance for other team members. About The Role Principal RWE Research Analyst Location – Hyderabad Hybrid About The Role: The Principal Real World Evidence (RWE) Research Analyst is responsible for the scientific and methodological aspects of all RWE projects as well as providing guidance for other team members. Key Responsibilities: Produce analytic results including full study reports for RWE or observational database analyses projects. Independently draft and edit documents such as high level research proposals, protocols and statistical analysis plans. Develop project timelines together with the Real World Evidence Data Scientists. Appropriately supervise communications with the customer as well as project related decisions taken. Conduct observational data analyses involving new creative approaches and supervise data management and statistical programming activities. Handle the outsourcing of programming activities from Data Science to an approved vendor in accordance with Scientific Services vendor management procedures. Provide guidance to conduct data quality reviews with detailed documentation. Present research and analysis results to customers and partners. Collaborate with RWE Center of Excellence (CoE) to drive quality and accuracy of results; constant improvements on systems, processes and quality matrices that contribute to existing solutions. Produce analysis datasets, listings, tables, and figures for research projects, according to specifications, while maintaining documentation and aligning with pre-defined project / study standards. Perform in-depth research and quantitative and qualitative analysis independently. Provide guidance to Associate RWE Research Analysts and RWE Research Analysts. Seek out opportunities for the development of new RWE services and new customers within Novartis. Maintain familiarity with technical developments in RWE, epidemiological and data science fields. Commitment to Diversity & Inclusion: : We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Essential Requirements: Graduation degree with 8+ years conducting research in the pharma industry, contract research organization, or academic institute; or experience in a closely related field within the pharma industry (e.g., clinical research, statistics, epidemiology, pricing). Master’s degree in a field such as epidemiology, biostatistics, statistics, bioinformatics, economics or similar. And 5+ years of proven experience conducting research in the pharma industry, contract research organization, or academic institute; or experience in a closely related field within the pharma industry. Experience in the application of statistical methods to the analysis of observational data. Technical proficiency in analytical and visualization tools and statistical programming languages such as SAS, R, R/shiny, Tableau, Spotfire, SPSS, STATA, WinBUGs. Deep knowledge of RWE data sources and standards such as MarketScan, CPRD, JMDC, Optum, PharMetrics, OMOP. Expert in applied statistics. Extensive experience in the application of statistical methods for analysis of observational data including propensity scores, sensitivity analyses, etc. is a plus. Good understanding of organizational processes. Extensive experience working cross-functionally with key internal partners. Open to experimentation and doing things differently to support creative thinking that leads to practical solutions to healthcare and business challenges. Holds a high standard on quality excellence. Continuously seeking to enhancing standards, technology through expansion of knowledge and training. Support partnership to swiftly and efficiently deliver innovative new products to patients and healthcare providers. High ethical values and standards. Able to speak out, challenge conventional thinking, and stand up for ideas. Experienced in data visualization Desirable Requirements: Ability to work, prioritize, and drive projects independently. Ability to handle multiple projects and partners. Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment To Diversity And Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Summary The Senior Principal Programmer is responsible for all statistical programming aspects of several studies, a medium to large sized project or project-level activities (incl. submission and postmarketing activities) The position is a key collaborator and strategic partner with biostatistics in ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high-quality deliverables. About The Role Major accountabilities: 1. Lead statistical programming activities as Trial Programmer for several studies or as a Lead/ Program Programmer for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization. 2. Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study or project level. 3. May act as functional manager for local associates including providing supervision and advice to these programmers on functional expertise and processes. 4. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as SP representative in study- or project-level team. 5. Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient CRT production. 6. Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. CSPD and other project-level strategies). 7. Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects. 8. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project. 9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. 10. Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. 11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance 12. Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures. Key Performance Indicators 1. Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers. 2. Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team/ project level meetings. Effectiveness of communication and team behaviors as assessed by the team members. 3. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager. 4. Ability and effectiveness as a programming representative on non-clinical initiatives. Ideal Background (State the preferred education and experience level) Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Languages: Fluent English (oral and written). Experience/Professional Requirement Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures) Proven communications and negotiation skills, ability to work well with others globally and influence Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others Ideally 7+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Company Description AlzaSyno Life Sciences is a CRO (Contract Research Organization) offering services in clinical operations, data management, biostatistics, medical writing, and regulatory affairs tailored to pharmaceutical, bio-pharmaceutical, medical device, and Ayurvedic sectors. Our services include study design and management, data collection and validation, statistical analysis, documentation preparation, regulatory submissions, and more. Role Description This is a full-time on-site role for a Business Development Manager located in Gurugram. The Business Development Manager will be responsible for identifying business opportunities, building and maintaining client relationships, developing strategic partnerships, and promoting the company's services to key stakeholders. Qualifications Business Development, Sales, and Client Relationship Management skills Excellent communication and negotiation skills Strategic thinking and problem-solving abilities Experience in the CRO industry or life sciences sector Bachelor's degree in Business, Life Sciences, or related field Knowledge of regulatory processes and industry standards Ability to travel as needed for client meetings and conferences Show more Show less