Description:
Job Description Summary
Step into a pivotal role where your expertise shapes the future of clinical development. As a Senior Principal Statistical Programmer, you will lead complex programming strategies across high-impact studies and programs, partnering with cross-functional teams to deliver high-quality, regulatory-ready outputs. This is your opportunity to influence innovation, drive modern programming practices, and make a tangible difference in bringing life-changing medicines to patients faster.
Key Responsibilities
- Lead SP activities as Trial Programmer for one or multiple trial(s) or as a Lead/Program Programmer for a program or an indication.
- May coordinate activities of internal/external programmers. Make SP decisions and propose strategies at study, program or indication/disease level.
- May act as functional manager of associates including providing supervision and guidance.
- Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects.
- Review eCRF, data structures, and ensure program-level standardization for effective pooling and efficient CRT production.
- Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements.
- Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects.
- 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.
- Understand Git-based version control workflows.
- Responsible for quality control and inspection readiness of all assigned statistical programming deliverables.
- Maintain up-to-date advanced knowledge of statistical programming languages (e.g. R, SAS) as well as industry requirements (e.g. CDISC, eCTD, Define.xml).
Essential Requirements
- BS/MS degree in statistics, computer science, mathematics, data science, life science or equivalent.
- Extensive experience in Statistical programming languages (e.g., R, SAS, Python) to drive standardization and adopt R packages, R Shiny, AI-enabled tools, version control, and reproducible workflows.
- Advanced experience in contributing to statistical analysis plans and constructing technical programming specifications.
- Advanced knowledge of CDISC data structures and solid understanding of standard programs.
- Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures).
- Proven communication and negotiation skills, ability to work well with others globally.
- Experience as Trial/Lead/Program Programmer for several studies or project-level activities including coordination of team.
Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together and rewarding the people who make it happen. In addition to base salary, you may be eligible for a performance-based bonus. Our benefits include insurance plans, retirement plans, wellbeing resources, global recognition programs, flexible and hybrid working options, and a minimum of 14 weeks paid parental leave.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.