Posted 24 days ago
Biostatistical Programming Manager
AmgenBiostatistical Programming Manager
Requirements
BA/BSc or higher in biostatistics, statistics, mathematics, or computer science, 6+ years statistical programming experience in clinical development, In-depth knowledge of CDISC SDTM, ADaM, and Define standards, Advanced SAS analysis and reporting skills, Experience leading statistical programming teams, Strong project management skills
Skills
SASCDISCSDTMADAMRPython
About the role
Responsibilities
- Serve as the Study Lead Programmer (SLP) for one or more clinical studies, managing end-to-end statistical programming activities
- Set programming strategies and ensure the quality, compliance, and timely delivery of all study deliverables
- Lead and manage programming teams, including assigning tasks and providing technical guidance and training
- Create and maintain programming specifications, including SDTM and ADaM standards
- Represent the Global Statistical Programming (GSP) function at Clinical Study Team (CST) meetings
- Perform hands-on statistical programming for complex deliverables and manage technical project aspects like computing environments
- Coordinate with cross-functional teams on study start-up activities, including CRF development and database specifications
Requirements
- BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or a related quantitative field
- At least 6 years of statistical programming experience within a clinical development environment
- In-depth knowledge of CDISC SDTM, ADaM, and Define standards
- Advanced SAS analysis and reporting skills, including experience with SAS/STAT packages
- Proven experience leading and managing statistical programming teams
- Strong project management and problem-solving skills
- Excellent oral and written English communication skills
Preferred Qualifications
- MSc or higher degree in a quantitative or scientific subject
- Prior experience with regulatory submissions for drug approval
- Familiarity with open-source programming tools such as R or Python
- Experience with automation platforms and emerging technologies in statistical programming
About the Company
Amgen is a leading biotechnology company dedicated to unlocking the potential of biology to serve patients with serious illnesses. By leveraging advanced human genetics and biologics manufacturing expertise, Amgen discovers and delivers innovative human therapeutics to millions of patients worldwide.
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Amgen · Hyderabad
