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 & compliance with timelines.
About the Role
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, like you, 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!
The Role
The Senior Principal Programmer is responsible for all statistical programming aspects of several studies, a medium to large sized project or project-level activities (incl. submission and post-marketing activities) The position is a key collaborator and strategic partner with biostatistics in ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high-quality deliverables.
Home Base Contract
Key Accountabilities:
- 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 in Novartis Global Development Organization.
- Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study or project level.
- May act as functional manager for local associates including providing supervision and advice to these programmers on 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 SP representative in study- or project-level team.
- Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient 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. CSPD and other project-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 CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project.
- 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
- Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.
Your experience:
- BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field
- Ideally 7+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry
- Expert SAS experience and proven skills in the use of SAS 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
- Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others
