Statistical Programming Lead
3 weeks ago
Role Description
MUM Fortrea Development India Pvt Ltd is seeking a highly skilled Statistical Programmer to join our team. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with clinical development, patient access, and technology solutions. In this role, you will be responsible for planning, executing, and overseeing all programming activities on a study, including resource estimation, working within budget, meeting timelines, maximizing quality, and interacting with other departments and clients.
- Develop and maintain SAS programs to create SDTM datasets, ADaM datasets, generate tables, listings, and figures, and perform QC of SDTM, ADaMs, and tables, listings, and figures.
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRF, and Reviewers Guides to support SDTM and ADaMs.
- Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of company and client standards.
- Review SAPs and TFL shells from a programming perspective.
- Mentor less-experienced programmers in the processes around SDTMs, ADaMs, and TFLs, ensuring adherence to department practices and processes.
- Present and share knowledge at department meetings.
- Respond to QA and client audits and support qualification audits.
- Contribute to proposal activities and participate in bid defense meetings to win new business.
- Continually identify and suggest ways to improve the efficiency, quality, and productivity of statistical programming.
MUM Fortrea Development India Pvt Ltd is seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. We offer a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
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