Novartis · 5 months ago
Principal Statistical Programmer
United States
Full-time
Remote
Senior Level, Lead/Staff
5+ years expNovartis is a global healthcare company focused on improving and extending people's lives. The Principal Statistical Programmer is responsible for all statistical programming aspects of large studies and acts as a key collaborator to ensure efficient execution of drug-development plans with high-quality deliverables.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development
Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level
Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT)
Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT
Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans
Provide and implement statistical programming solutions; ensure knowledge sharing
In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets
Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications
Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results
Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings
Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance
As assigned, act as subject matter expert (SME) or contribute to process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures
Qualification
Required
BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field
Ideally 5+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry
Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables
Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications
Good knowledge of industry standards including CDISC data structures as well as 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)
Good communications and negotiation skills, ability to work well with others globally
Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
H1B Sponsorship
Novartis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
2026-01-11
Morningstar.com
2026-01-11
Company data provided by crunchbase