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Tier-1 employer and metro location increase competition, but niche biostatistics skills reduce applicant density.
Strong clinical, regulatory, and CDISC requirements make skills less transferable across industries.
Mandatory SAS/R, CDISC, and explicit postgraduate experience create strict technical and experience filters.
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Author and review statistical analysis plans, data specifications, and conduct primary and secondary endpoint analyses for clinical trials.
Ensure accuracy and regulatory compliance of datasets and outputs adhering to CDISC standards and Amgen SOPs.
Collaborate cross-functionally with Clinical Study Teams and programming colleagues for timely delivery of study outputs and contribute to clinical and regulatory documentation.
Master’s degree in Statistics/Biostatistics or related field with 4 years pharmaceutical industry or medical research experience, OR Doctorate with 2 years experience.
Competency in statistical programming using SAS or R.
Experience applying statistical methods in clinical trial analysis and conduct.
Location: Position based in Hyderabad, India.
Experienced in authoring statistical documents including SAPs and capable of leading studies/projects with minimal oversight.
Familiarity with CDISC standards (SDTM, ADaM) and understanding of drug development statistical applications.
Skillful in cross-functional collaboration and leveraging AI/automation tools to enhance efficiency in biostatistics processes.