Biostatistical Programming Mgr

Amgen Inc. (IR); Hyderabad; On-site; INR 1,000,000 - 1,500,000; Full time

Benefits offered by this job

Generous Total Rewards Plan

Opportunities for professional growth

Diverse and inclusive community

Job summary

A global biotechnology company in Hyderabad is seeking a Biostatistical Programming Manager to lead statistical programming activities for clinical studies. The ideal candidate will have a degree in biostatistics or a related field, with at least 6 years of experience and a strong background in clinical trial operations. Responsibilities include managing programming tasks, ensuring quality deliverables, and providing guidance to a team of statistical programmers. This role offers opportunities for professional growth within a diverse and inclusive environment.

Qualifications

• At least 6 years of statistical programming experience in clinical development.
• Proven record of statistical programming and problem-solving skills.
• In-depth knowledge of CDISC SDTM, ADaM, and Define standards.

Responsibilities

• Lead statistical programming activities for multiple studies.
• Manage programming tasks and ensure quality deliverables.
• Provide guidance and training to team members.

Skills

Statistical programming experience

Clinical trial operations

SAS analysis and reporting

Project management

Problem-solving skills

Knowledge of CDISC standards

Communication skills

Education

BA/BSc or higher degree in biostatistics, statistics, or related field

Tools

SAS

R

Python

Job description

## **Career Category**Clinical Development## ## **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).**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 questionsPreferred 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.