Biostatistical Programming Manager

Job title: Biostatistical Programming Manager

About the Role Amgen is expanding its Global Statistical Programming capabilities, with Amgen India playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Manager, you will serve as the Study Lead Programmer for one or more studies and lead a team of statistical programmers to support all statistical programming activities within a study. You may also support regulatory submissions.

What You'll Do

• Serve as Study Lead Programmer for one or more studies and lead a team of statistical programmers to support all programming activities within a study
• Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables
• Lead and manage specific programming tasks, including all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions
• Participate in establishing the programming scope for a deliverable with the statisticians and the study team
• Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project
• Create and maintain programming related specifications for the studies/projects
• Represent GSP at the Clinical Study Team
• Attend meetings for, and provide programming input into, cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review, data quality check specifications
• Initiate cross-functional team meetings as necessary
• Perform significant hands-on statistical programming, particularly for those most challenging deliverables
• Manage individual programmer work assignments to ensure timely, high-quality deliverables
• Provide technical leadership and guidance for study programming team
• Coordinate and monitor data issue reporting and resolution
• Coordinate with other SLPs to provide consistent deliverables across studies within a product
• Manage technical aspects of project, including creating and managing computing environment, lookup tables, etc.
• Provide training and guidance to other programmers
• Assume some product level responsibilities as delegated by Global Programming Lead and/or Programming Execution Lead
• This position will be located at Amgen India (Hyderabad).

What We're Looking For

• BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 6 years of statistical programming experience in clinical development environment
• Thorough understanding of clinical trial processes, from data collection to analysis reporting
• Proven record of superior statistical programming and problem-solving skills within clinical development environment
• Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities for a study end-to-end
• In-depth knowledge on latest CDISC SDTM, ADaM, and Define standards along with strong ability to implement all aspects of those standards
• Advanced analysis and reporting skills in SAS, including SAS/STAT packages, among others
• Experience in data quality and compliance check tools
• Excellent project management skills and ability to lead multiple projects effectively
• Excellent oral and written English communication skills
• Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
• Willingness and ability to provide guidance to team members on technical and process questions

Preferred Skills

• MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
• Familiarity with open-source programming tools, automation platforms, and emerging technologies in statistical programming
• Prior regulatory submission experience for drug approval

Nice to Have

• Additional advanced degrees as noted above

Compensation & Benefits

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits