Biostatistical Programming Manager

Biopharma Careers; Hyderabad; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Biopharma Careers seeks a Biostatistical Programming Manager in Hyderabad to lead study programming teams and serve as Study Lead Programmer for multiple trials.

You will set the programming strategy, oversee SDTM/ADaM specifications, and collaborate with statisticians and CST members to ensure high-quality deliverables for regulatory submissions.

Qualifications

• BA/BSc or higher in biostatistics, statistics, mathematics, computer science, or related quantitative fields with at least 6 years of statistical programming experience.
• Proven record of superior statistical programming and problem-solving in clinical development.
• In-depth knowledge of CDISC SDTM/ADaM/Define standards and ability to implement all aspects.

Responsibilities

• Lead one or more studies end-to-end as Study Lead Programmer.
• Set programming strategy, ensure timelines, quality and compliance of deliverables.
• Lead and manage specific programming tasks for regulatory submissions.
• Create and maintain programming specifications (SDTM/ADaM) for studies/projects.
• Coordinate cross-functional study start-up activities and provide programming input.

Skills

SAS

CDISC SDTM/ADaM

English communication

Project management

Team leadership

Cross-cultural collaboration

R / Python familiarity

Education

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

MSc in statistics/biostatistics (preferred)

Tools

R

Python

Job description

Career Category

Clinical

Job 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).

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

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