Senior Principal Statistical Programmer
Job ID: REQ-10031235
Apr 01, 2025
India
Summary
The Senior Principal Programmer is responsible for all statistical programming aspects of several studies, a medium to large-sized project, or project-level activities (including submission and post-marketing activities). This position serves as a key collaborator and strategic partner with biostatistics in ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high-quality deliverables.
About the Role
Major Accountabilities:
Lead statistical programming activities as Trial Programmer for several studies or as Lead/Program Programmer for a medium to large-sized project in phase I to IV clinical studies within Novartis Global Drug Development.
Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at 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 status of deliverables and critical programming aspects (e.g., timelines, scope, resource plan).
Review eCRF, discuss data structures, and ensure project-level standardization to allow pooling and efficient CRT production.
Comply with company, department, and industry standards (e.g., CDISC). Assess and clarify programming requirements, and review and develop programming specifications as part of analysis plans.
Provide and implement statistical programming solutions; act as a programming expert in problem-solving aspects.
Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions, safety reports, publications, post-marketing activities, or exploratory analyses.
Maintain up-to-date knowledge of 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 agreed contracts and internal business guidance.
Act as a subject matter expert (SME) or lead process improvement/non-clinical project initiatives related to programming and analysis reporting procedures.
Key Performance Indicators:
Quality and timeliness of statistical programming deliverables, assessed by internal and external customers.
Adequate representation of the Statistical Programming function in Clinical Trial Team/project-level meetings.
Ability and effectiveness in training, mentoring, and coordinating internal and external programmers.
Effectiveness as a programming representative on non-clinical initiatives.
Ideal Background
Education (minimum/desirable):
BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences, or related fields.
Languages: Fluent in English (oral and written).
Experience/Professional Requirements:
Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables, including advanced MACRO development.
Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications.
Advanced knowledge of industry standards, including CDISC data structures, and a solid understanding of the development and use of standard programs.
Good understanding of regulatory requirements relevant to Statistical Programming (e.g., GCP, study procedures).
Proven communication and negotiation skills, with the ability to work well globally and influence teams.
Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of internal and external programmers.
Ideally 7+ years of work experience in a programming role, preferably supporting clinical trials or in the pharmaceutical industry.
Why Novartis
Helping people with disease and their families takes more than innovative science. It requires a community of smart, passionate individuals like you who collaborate, support, and inspire each other. Together, we can achieve breakthroughs that change patients' lives.
Ready to create a brighter future together? Learn more about Novartis' people and culture.
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Benefits and Rewards
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Job Details
Division: Development
Business Unit: Innovative Medicines
Location: India (Mumbai)
Company/Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full time
Employment Type: Regular
Shift Work: No
Accessibility and accommodation
Novartis is committed to providing reasonable accommodations for individuals with disabilities. If you need assistance during the recruitment process or in performing essential job functions due to a medical condition or disability, please reach out to us at diversityandincl.india@novartis.com, including your job requisition number.
Novartis is dedicated to building an inclusive work environment and diverse teams, representative of the patients and communities we serve.
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