Senior Principal Statistical Programmer

Healthcare Businesswomens Association

Job Description Summary

Responsible for all statistical programming, data review, reporting, and analytics development aspects of several studies, including medium to large-sized projects or project-level activities. Acts as a key collaborator and strategic partner to ensure efficient execution of drug development plans with timely and high-quality deliverables. Ensures compliance with project/study standards and specifications, following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting, and adherence to timelines.

Job Description

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.

We are optimizing and strengthening our processes and ways of working, investing in new technologies, and building therapeutic area and platform capabilities to bring medicines to patients faster.

We seek talented individuals like you to join us and help give people with disease and their families a brighter future.

Apply today and join a team where we thrive together!

The Role

The Senior Principal Programmer is responsible for all statistical programming aspects of several studies or project-level activities, including submission and post-marketing activities. The role is a key collaborator and strategic partner with biostatistics, ensuring efficient execution of pharmaceutical drug-development plans within Novartis Global Drug Development with high-quality and timely deliverables.

Key Accountabilities:

• Lead statistical programming activities as Trial Programmer for multiple studies or as Lead/Programmer for medium to large projects across phases I to IV.
• Coordinate activities of internal or external programmers, make programming decisions, and propose strategies at study or project level.
• May serve as functional manager for local associates, providing supervision and advice on programming expertise and processes.
• Build and maintain effective relationships with cross-functional teams, summarizing and discussing deliverables, timelines, scope, and resources, representing programming in study or project teams.
• Review eCRF, data structures, and activities to ensure project standardization for efficient pooling and CRT production.
• Ensure compliance with standards (e.g., CDISC), assess requirements, and develop programming specifications as part of analysis plans.
• Provide and implement statistical programming solutions, share knowledge, and act as a problem-solving expert.
• Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions, safety reports, publications, and post-marketing activities.
• Maintain quality control and audit readiness of programming deliverables, ensuring accuracy and reliability of analysis results.
• Keep up-to-date with advanced programming software (e.g., SAS) and industry requirements (e.g., CDISC SDTM/ADaM, eCTD, Define.xml), attending functional meetings and trainings.
• Establish effective working relationships with external associates according to contracts and guidelines.
• Act as SME or lead process improvement initiatives related to programming and reporting procedures.

Your experience:

• BA/BS/MS or equivalent in statistics, computer science, mathematics, life sciences, or related fields.
• Experience in a programming role supporting clinical trials or in the pharmaceutical industry.
• Expertise in SAS and development of advanced MACROs within a statistical programming environment.
• Experience in contributing to analysis plans and developing programming specifications.
• Knowledge of industry standards including CDISC data structures and development of standard programs.
• Understanding of regulatory requirements (e.g., GCP, study procedures).
• Strong communication and negotiation skills, with the ability to work globally and influence others.
• Experience as Trial/Lead/Project Programmer managing multiple studies or projects, with team coordination skills.

Why Novartis: Helping people with disease and their families requires innovative science and a community of passionate people. Join us to create a brighter future together:

Commitment to Diversity & Inclusion:

We are committed to building an inclusive work environment and diverse teams that reflect the communities we serve.

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Skills Desired: Classification Systems, Clinical Trials, Data Storage, Programming Languages, Data Analysis, Data Structures, Initiative, Reporting, Statistical Analysis