Description
**Biostatistical Programming Manager**
**What you will do**
Let’s do this. Let’s change the world.
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
+ Manage technical aspects of project (e.g., create/manage computing environment, lookup tables, etc.)
+ 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
