Novartis · 16 hours ago
Associate Director Statistical Programming
Cambridge (Massachusetts)
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$146K/yr - $270K/yr
6+ years expNovartis is a leading pharmaceutical company dedicated to reimagining medicine to improve and extend people's lives. The Associate Director of Statistical Programming will be responsible for overseeing statistical programming activities for clinical trials, ensuring timely and quality deliverables while managing resources and leading cross-functional collaborations.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Lead statistical programming activities for multiple clinical trials within a program or an indication /disease area, or development program
Accountable for timely and quality development and validation of all statistical programming components on assigned program(s). Responsible for audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results
Coordinate activities of internal / external programmers. Make statistical programming decisions and propose strategies at program or indication/disease level. Develop scientific documentation for the program(s) or indication/disease area together with the Biostatistician(s)
Responsible for allocating resources within a program and ensuring resource sharing between programs to meet AQS and organizational goals
May act as an operational and/or functional manager of associates including providing supervision and guidance to these programmers on operational / functional expertise and processes
Recruit, mentor, and develop statistical programmers
Build and maintain effective working relationships with cross-functional team members within the clinical trial/program, and able to summarize and discuss status of deliverables and critical programming aspects with them (timelines, scope, resource plan)
Maintain up-to-date advanced knowledge of programming software (e.g. SAS/R) as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training
Represent statistical programming at indication or program-level, in audits/inspections and Health Authority (HA) meetings, and on technical programming aspects in external conferences or consortiums (e.g. CDISC)
Offer expert technical and professional recommendations, thought leadership for the SP function at the indication/ program level or for non-clinical initiatives
Qualification
Required
BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 6+ years in a programming or statistical role
3+ years experience in a line management or equivalent leadership experience, such as matrix management (applicable for people managers only). Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met
In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP)
Expert in SAS or R programming, including the development and validation of deliverables within a Statistical Programming environment, and the creation of advanced MACROs and/or functions
Significant experience in contributing to statistical analysis plans and developing technical programming specifications
Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs
At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications, including the coordination of large teams of internal and/or external programmers
Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders
Preferred
10+ years experience in a programming or statistical role equivalent
Benefits
Health, life and disability benefits
A 401(k) with company contribution and match
A 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
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