About this role
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
- Ability to provide quality output and deliverables in adherence with challenges and timelines