Senior Principal Statistical Programmer

Novartis-posted 2 months ago

$119,700 - $222,300/Yr

Full-time • Senior

East Hanover, NJ

Chemical Manufacturing

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The Statistical Programming community at Novartis comprises of approximately 350 (internal) statistical programmers and belongs to the Advanced Quantitative Sciences (AQS) organization which also includes more than 450 biostatisticians, pharmacometricians and data scientists supporting the entire portfolio of clinical projects across the Research, Development and Commercial spectrum. In this role, you will be responsible for all statistical programming (SP) aspects of several studies, a medium to large sized program or program-level activities (incl. submission and post-marketing activities). You will be a key collaborator and strategic partner with cross-functional team members within the clinical trial/program, ensuring the integrated/clinical development/evidence plans are executed efficiently with timely and high-quality deliverables.

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.
Coordinate activities of internal/external programmers.
Make SP decisions and propose strategies at study, program or indication/disease level.
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 relationships with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan).
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.
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.
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).
Act as subject matter expert (SME) on process improvement/non-clinical initiatives with a focus on programming.

BS/MS degree in statistics, computer science, mathematics, life science or equivalent relevant degree.
7+ years of work experience in a programming role preferably supporting clinical trials or in the pharmaceutical industry.
Experience as Trial/Lead/Program Programmer for several studies or project-level activities, including coordination of a team of internal or external programmers.
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.
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.

Working knowledge of R is desirable, though not essential.

Comprehensive benefits package including health, life and disability benefits.
401(k) with company contribution and match.
Generous time off package including vacation, personal days, holidays and other leaves.
Performance-based cash incentive and eligibility for annual equity awards.

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