Biostatistical Programming Senior Associate (POPPK/PD)
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Job Description
Structured overview of role & requirementsAbout This Role
Perform hands-on statistical programming for clinical trial analysis and regulatory submissions using SAS and/or R.
Create, validate, and manage complex SDTM, ADaM datasets and related tables, listings, and figures for safety and efficacy data.
Support Population PK/PD dataset creation and lead or back up small projects in this area, ensuring timely delivery of high-quality outputs.
Minimum Requirements
Bachelor’s degree (BA/BSc) or higher in biostatistics, statistics, mathematics, computer science, or related quantitative/scientific field.
At least 4 years of statistical programming experience in clinical development environment.
Working knowledge of CDISC SDTM standards and familiarity with CDISC ADaM and Define standards.
Proficiency in SAS/STAT packages and ability to handle complex clinical trial data for regulatory submissions.
Ideal Candidate Profile
Experienced in global collaboration and managing multiple projects across therapeutic areas with adherence to timelines.
Capable of leading small teams and providing technical guidance, especially in Population PK/PD dataset programming.
Familiar with pharmacokinetic/pharmacodynamic data and the drug development life cycle, with prior regulatory submission exposure.
