Biostatistical Programming Manager

Career Category

Research

Job Description

Biostatistical Programming Manager

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

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