Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Manager, you will serve as the Study Lead Programmer (SLP) 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.
Key Responsibilities:
Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer
Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables
Lead and manage specific programming tasks (e.g., all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions) assigned to the team
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 (e.g., SDTM and ADaM) for the studies/projects
Represent GSP at the Clinical Study Team (CST)
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 providing consistent deliverables across studies within a product
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Provide training and guidance to other programmers
Assume some product level responsibilities as delegated by Global Programming Lead (GPL) and/or Programming Execution Lead (PEL).
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 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 (including preparing data and programming specifications) 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 (R, Python), automation platforms, and emerging technologies in statistical programming
Prior regulatory submission experience for drug approval
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
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
About Amgen
Pharmaceuticals & Biotech10,001+Founded 1980
Amgen is a global biotechnology company that discovers, develops, manufactures and delivers innovative medicines for serious diseases, including cancer, heart disease, inflammatory conditions and rare diseases.
