Senior Manager, Biostatistical Programming
Amgen (company site, opens in a new tab)8+ yrsHyderabadOn-siteDirect career pageEst. 30–45 LPA
Posted on 1 Sept
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Job description
Structured overview of role & requirements
About This Role
- Lead and manage an offshore statistical programming team for successful delivery of programming milestones and regulatory submission packages across one or more product areas.
- Collaborate with Global Programming Lead to implement global programming strategies, manage resource plans, budgets, and oversee progress and issue resolution for programming projects.
- Drive process improvements, oversee compliance audits, develop and enforce global policies/SOPs, provide coaching and career development for programming staff.
Minimum Requirements
- Bachelor’s degree or higher in biostatistics, statistics, mathematics, computer science, or related quantitative/scientific field.
- Minimum 8 years of statistical programming experience in clinical development environment.
- Strong expertise in SAS programming including advanced analysis and reporting (SAS/STAT, Macro, Graph, SQL).
- Experience leading offshore programming teams and working with regulatory submission activities for drug approval.
Ideal Candidate Profile
- Experienced leader capable of managing globally dispersed, cross-cultural teams and delivering end-to-end programming for clinical studies.
- Technically adept with strong knowledge of clinical trial operations, data quality, compliance, and software development lifecycle.
- Skilled at developing staff, managing budgets, and facilitating cross-functional collaboration and process improvements.