Senior Principal Statistical Programmer
Job ID: REQ-10031208
Date Posted: Apr 01, 2025
Location: India (Hyderabad Office)
Summary
The Senior Principal Programmer is responsible for leading all statistical programming activities for several studies or medium to large-sized projects, including submission and post-marketing activities. This role is integral in collaborating with biostatistics to ensure the successful execution of pharmaceutical drug development plans within Novartis Global Drug Development, ensuring high-quality and timely deliverables.
About the Role
Major Accountabilities:
Lead statistical programming activities as Trial Programmer for several studies or as Lead/Program Programmer for medium to large-sized projects in Phase I-IV clinical studies.
Coordinate activities of programmers (internally or externally), make statistical programming decisions, and propose strategies at the study or project level.
May act as functional manager for local associates, providing supervision and advice on functional expertise and processes.
Build and maintain effective working relationships with cross-functional teams, summarizing and discussing the status of deliverables and critical programming aspects (timelines, scope, resource plan).
Review eCRF, discuss data structures, and review activities to ensure project-level standardization, enabling efficient CRT production.
Ensure compliance with company, department, and industry standards (e.g., CDISC), assess programming requirements, and influence the development of programming specifications as part of the analysis plans.
Implement statistical programming solutions and ensure knowledge sharing across the team. Act as a programming expert in problem-solving.
Ensure timely development and validation of datasets and outputs for CSRs, regulatory submissions, safety reports, publications, post-marketing activities, or exploratory analyses.
Ensure quality control and audit readiness of all statistical programming deliverables, maintaining accuracy and reliability in statistical analysis results.
Stay current with programming software (e.g., SAS) and industry requirements (e.g., CDISC SDTM/ADaM, eCTD, Define.xml).
Establish successful working relationships with external associates according to contract and internal business guidance.
Act as a subject matter expert (SME) or lead process improvement initiatives focused on programming and analysis reporting procedures.
Key Performance Indicators:
Quality and timeliness of statistical programming deliverables as assessed by internal and external customers.
Effective representation of Statistical Programming as Trial/Lead/Program Programmer in team meetings.
Ability to train, mentor, and coordinate programmers assigned to the same study/project.
Effectiveness as a programming representative on non-clinical initiatives.
Ideal Background
Education:
BA/BS/MS or equivalent in statistics, computer science, mathematics, life sciences, or a related field.
Fluent in English (oral and written).
Experience/Professional Requirements:
Expert SAS experience with proven skills in developing and validating deliverables, including advanced MACRO development.
Advanced experience in contributing to statistical analysis plans and constructing technical programming specifications.
Advanced knowledge of industry standards, including CDISC data structures, and a solid understanding of developing and using standard programs.
Understanding of regulatory requirements relevant to statistical programming (e.g., GCP, study procedures).
Proven communication and negotiation skills with the ability to work globally and influence others.
Experience as Trial/Lead/Project Programmer for several studies, including coordinating teams of internal or external programmers.
Ideally 7+ years of experience in a programming role supporting clinical trials or the pharmaceutical industry.
Why Novartis
At Novartis, we combine innovative science with a community of passionate, smart people. By collaborating and supporting each other, we achieve breakthroughs that change patients' lives. If you’re ready to be part of a brighter future, we invite you to join us.
Learn more about Novartis' culture: People and Culture
Join our Novartis Network to stay updated on career opportunities: Novartis Talent Network
Discover Benefits and Rewards: Novartis Benefits
Division:
Development
Business Unit:
Innovative Medicines
Location:
India (Hyderabad)
Functional Area:
Research & Development
Employment Type:
Full time (Regular)
Shift Work:
No
Accessibility and Accommodation:
Novartis is committed to providing reasonable accommodation to individuals with disabilities. If you need accommodation for any part of the recruitment process or to perform essential job functions, please email diversityandincl.india@novartis.com with your request and contact information, and include the job requisition number.
Novartis is committed to building an inclusive work environment with diverse teams representing the patients and communities we serve.
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