Biostatistical Programming Senior Associate

What you will do

• Let’s do this. Let’s change the world.
• Amgen is expanding its global Statistical Programming capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Senior Associate, you will perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions.
• Key Responsibilities:
• Analysis and reporting of clinical trial data using SAS and/or R
• Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy
• Creation and validation of complex tables, listings, and figures, both safety and efficacy
• Prepare statistical programming specifications
• Prepare statistical programming related documents for regulatory submissions
• Maintain tracking and validation documentation
• Collaborate with cross-functional team and create and/or validate complex programs for checking data quality
• Interact and collaborate with study team members from other functions globally
• Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP
• This position will be located at Amgen India (Hyderabad).
• Win
• What we expect of you
• We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation.
• Basic Qualifications:
• BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 4 years of statistical programming experience in relevant career statistical programming experience in a clinical development environment.
• Familiarity with drug development life cycle and excellent skills with the manipulation, analysis and reporting of complex clinical trial data
• Ability to effectively perform complex statistical programming and related tasks