Biostatistics Sr Assoc (Study Statistician)
On-siteHyderabad, Telangana, India
Job Summary
Author and review statistical documents including Statistical Analysis Plans, TFL shells, and submission data file specifications for clinical trials across the drug development lifecycle. Conduct primary, secondary, and exploratory endpoint analyses, perform dose-level review support, and execute quality control of datasets to ensure CDISC compliance. Collaborate cross-functionally in Clinical Study Team meetings, support external supplier reviews, and maintain Trial Master File statistical sections. Participate in regulatory submissions and clinical publications while staying current on new methodologies and guidelines. This role is based in Amgen India (Hyderabad) and requires a Master's or Doctoral degree in Statistics/Biostatistics with relevant industry experience.
Required Qualifications
- Master's degree in Statistics/Biostatistics (or related subject with high statistical content) with 4 years post-graduate experience as a statistician in the pharmaceutical industry or medical research
- Doctoral degree in Statistics/Biostatistics (or related subject with high statistical content) with 2 years post-graduate experience
- Competency in statistical programming (SAS or R)
- Experience applying statistical methods in the analysis and conduct of clinical trials
- Ability to clearly communicate in English, both written and oral
Desired Qualifications
- Master's degree with 6+ years post-graduate experience
- Doctorate with 4+ years
- Prior leadership of at least 1 study/project with minimal oversight
- Experience authoring protocols, SAPs, and reviewing CSRs
- Familiarity with CDISC standards (SDTM, ADaM)
- Experience with AI/automation tools to drive efficiency
- Strong understanding of drug development and statistical applications across the clinical lifecycle
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