Lead Clinical Data Scientist

1 week ago

chennai, India beBeeStatistical Full time

Sponsor-dedicated roles provide an opportunity to drive innovation in pharmaceutical companies. As a Principal Statistical Programmer, you will be part of a global team working on clinical development programs for various therapeutic areas.This role reports directly to the Director, Biostatistics and Programming in our organization's services business unit. The Principal Statistical Programmer works independently, tracking progress and providing technical support to team members.The key responsibilities include:Generating SDTM, ADaM specifications, datasets, reviewer's guide, and define.xml files for multiple studies.Developing SAS programs to generate datasets, complex listings, tables with descriptive statistics, and graphs.Delivering high-quality statistical programming results, including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs.Participating in overseeing CROs' statistical programming deliverables for multiple clinical studies to ensure high-quality and meet pre-specified timelines.Supporting the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses.The position requires a bachelor's degree in computer science, data science, mathematics, or statistics, along with 7+ years of experience as a Statistical Programmer in a biotech/pharma clinical development biometrics team. Strong SAS programming skills, expertise in CDISC standards, medical terminology, and FDA/ICH regulation are essential.

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