Novartis · 1 day ago
Senior Principal Statistical Programmer
East Hanover
Full-time
Onsite
Senior Level, Lead/Staff
$120K/yr - $222K/yr
7+ years expNovartis is a leading pharmaceutical company focused on reimagining medicine to improve and extend people’s lives. The role involves leading statistical programming activities for clinical trials, ensuring high-quality deliverables, and collaborating with cross-functional teams to support clinical development efforts.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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 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 to these programmers on operational / functional expertise and processes
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 statistical programming representative in study- or program-level team
Review eCRF, data structures, and ensure program-level standardization for effective pooling and efficient case record tabulation (CRT) production
Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. program-level strategies)
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 clinical study reports (CSRs), regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/program
Responsible for quality control and inspection 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, R) as well as industry requirements (e.g. CDISC, eCTD, Define.xml). May act as subject matter expert (SME) on process improvement/non-clinical initiatives with a focus on programming
Qualification
Required
BS degree in statistics, computer science, mathematics, life science or equivalent relevant degree and 7+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry
Experience as Trial/Lead/Program Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/program, ability to transfer own knowledge to others
Expert SAS/R experience and proven skills in the use of SAS/R within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs
Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications
Advanced 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)
Proven communications and negotiation skills, ability to work well with others globally and influence
Preferred
MS or Ph.D degree in statistics, computer science, mathematics, life science, or equivalent
Benefits
Performance-based cash incentive
Annual equity awards
Health, life and disability benefits
401(k) with company contribution and match
Generous time off package including vacation, personal days, holidays and other leaves
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
2026-01-08
2026-01-08
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