Senior Principal Statistical Programmer

Role Summary

The Senior Principal Statistical Programmer will be responsible for all statistical programming (SP) aspects of several studies or program-level activities within the Novartis Advanced Quantitative Sciences (AQS) organization, acting as a key collaborator and strategic partner to ensure high-quality deliverables and efficient execution across clinical development programs.

Responsibilities

• Lead statistical programming activities as a trial programmer for one or multiple trial(s) or as a lead/program programmer for a program or indication.
• Coordinate activities of internal or external programmers, make SP decisions, and propose strategies at study, program, or indication/disease level.
• Act as functional manager of associates, providing supervision and guidance on operational/functional expertise and processes.
• Build and maintain effective working relationships with cross-functional teams, summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan) as the SP representative in study- or program-level teams.
• Review eCRF and data structures, and ensure program-level standardization for effective pooling and efficient CRT production.
• Comply with company/department/industry standards (e.g., CDISC) and processes; review, develop, and influence programming specifications as part of analysis plans (including program-level strategies).
• Provide and implement statistical programming solutions; ensure knowledge sharing and act as programming expert in problem-solving.
• Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities, or exploratory analyses as required.
• Be responsible for quality control and inspection readiness of all assigned statistical programming deliverables and the accuracy/reliability of statistical analysis results.
• Maintain up-to-date advanced knowledge of programming software (e.g., SAS, R) and industry requirements (e.g., CDISC, eCTD, Define.xml); may act as SME on process improvement/non-clinical initiatives with a focus on programming.

Qualifications

• Essential: BS/MS in statistics, computer science, mathematics, life sciences or equivalent; 7+ years in a programming role preferably supporting clinical trials or in the pharmaceutical industry.
• Experience as Trial/Lead/Program Programmer for several studies or project-level activities, including coordinating teams of internal/external programmers and transferring knowledge to others.
• Expert SAS/R experience with proven skills in developing and validating deliverables; proven experience in developing advanced macros.
• Advanced experience contributing to statistical analysis plans and/or constructing technical programming specifications.
• Advanced knowledge of industry standards including CDISC data structures and understanding of standard programs development and use.
• Good understanding of regulatory requirements relevant to Statistical Programming (e.g., GCP, study procedures).
• Proven communication and negotiation skills; ability to work well with teams globally and influence others.

Skills

• Statistical programming (SAS, R); data standards and structures (CDISC); regulatory submissions processes (eCTD, Define.xml)
• Program management and cross-functional collaboration; problem-solving and decision-making
• Technical writing and development of analysis plans; macro development

Education

• BS/MS degree in statistics, computer science, mathematics, life science or equivalent

Additional Requirements

• Desirable: working knowledge of R is beneficial