Biostatistical Programming Manager

Amgen; Hyderabad; On-site; INR 3,500,000 - 6,000,000; Full time

Benefits offered by this job

Professional growth

Diversity & inclusion

Total rewards plan

Job summary

Amgen India (Hyderabad) is seeking a Biostatistical Programming Manager to lead study programming activities across regions. You will serve as the Study Lead Programmer, mentor a team of programmers, and guide statistical programming for regulatory submissions.

This role emphasizes SDTM/ADaM expertise, SAS proficiency, and cross-functional collaboration, with a focus on delivering high-quality results. Ideal candidates have strong English communication, project management skills, and the ability

Qualifications

• BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science or related quantitative fields, with at least 6 years of statistical programming experience.
• Strong understanding of clinical trial processes from data collection to analysis reporting.
• Proven track record in statistical programming and problem-solving within a clinical development environment.
• Experience leading and managing statistical programmers for end-to-end study programming.
• In-depth knowledge of CDISC SDTM, ADaM and Define standards and ability to implement them.
• Advanced SAS programming and reporting skills including SAS/STAT.
• Experience with data quality and compliance tools.
• Excellent project management and leadership capabilities.
• Excellent spoken and written English communication and ability to work with globally dispersed teams.
• Willingness to guide and mentor team members on technical and process questions.

Responsibilities

• Lead one or more studies end-to-end and assume responsibilities of Study Lead Programmer.
• Set programming strategy for studies, ensuring timelines, quality and compliance.
• Lead and manage programming tasks for analyses supporting regulatory submissions.
• Establish programming scope with statisticians and study team.
• Develop detailed timelines to ensure timely delivery of programming deliverables.
• Create and maintain SDTM/ADaM specifications and other programming documents.
• Represent GSP at CST and participate in cross-functional start-up activities.
• Perform hands-on statistical programming for complex deliverables.
• Coordinate data issue reporting and resolution across the team.
• Provide technical leadership and guidance to the study programming team.

Skills

Leadership

Project management

English communication

SAS programming

Cross-cultural collaboration

Problem-solving

Education

BA/BSc or higher in biostatistics/ statistics/ mathematics/ computer science

MSc or higher in statistics/ biostatistics

Tools

SAS

SAS/STAT

CDISC SDTM

CDISC ADaM

R

Python

Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

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