Job Description Summary Location: Basel, Switzerland
Working Model: Hybrid (12 days per month on-site)
Alternate Location: London, United Kingdom
Working models: Hybrid (12 days per month on-site if living within 50 miles of our London office) or Remote (if living beyond 50 miles of our London office)
Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high-quality deliverables. Complies with project/study standards and specifications following internal and regulatory guidelines. Oversees programming style quality of statistical reporting and compliance with timelines.
Job Description Summary Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities all to bring our medicines to patients even faster. We are seeking key talent to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together!
Senior Principal Programmer – Key Responsibilities Lead statistical programming activities as Trial Programmer for several studies or as Lead/Program Programmer for a medium to large sized project in phase I to IV clinical studies.
Coordinate activities of programmers internally or externally; make statistical programming decisions and propose strategies at study or project level.
May act as functional manager for local associates providing supervision and advice on functional expertise and processes.
Build and maintain effective working relationships with cross-functional teams; summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan).
Review eCRF, data structures and activities to ensure project-level standardization enabling pooling and efficient CRT production.
Comply with CDISC and other industry standards; assess and clarify programming requirements; review and influence programming specifications as part of analysis plans (incl. CSPD and other project-level strategies).
Provide and implement statistical programming solutions; ensure knowledge sharing; act as programming expert in problem-solving.
Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses as required.
Responsible for quality control and audit readiness of all assigned statistical programming deliverables and the accuracy and reliability of results.
Maintain up-to-date knowledge of programming software (e.g., SAS) and industry requirements (e.g., CDISC SDTM/ADaM, eCTD); attend functional meetings and trainings.
Establish working relationships on individual studies with external associates according to contracts and internal guidance.
Act as SME or lead process improvement/non-clinical project initiatives focusing on programming and analysis reporting procedures.
Your experience BA/BS/MS or international equivalent in statistics, computer science, mathematics, life sciences, or related field
Work experience in a programming role preferably supporting clinical trials or in pharmaceutical industry
Expert SAS experience in a Statistical Programming environment with development and validation of deliverables; experience developing 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 and development/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 with others globally and influence
Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of teams of internal or external programmers
Accessibility and Inclusion Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or to receive more detailed information about essential functions of a position, please send an email with the job requisition number in your message.
Skills Desired
Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis
Required Experience:
Staff IC
Job Description Summary
Location: Basel, Switzerland
Working Model: Hybrid (12 days per month on-site)
Alternate Location: London, United Kingdom
Working models: Hybrid or Remote as described above
Senior Principal Programmer • Basel, Basel-Stadt, Switzerland
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