Mylene Paumier is recruiting for a Senior Principal Programmer to join a global pharmaceutical company at their site based in Basel on a permanent basis.
As Senior Principal Programmer, you will be responsible for:
- The integrity of the programming/computing solutions for a major, complex global drug development program with multiple clinical indications/projects or for multiple drug development programs across CSUs within the Franchise
- Lead the full execution of final production output generation of quality, timely programming deliverables for CSRs, regulatory submissions/interactions, publications, and market promotions within the drug development program(s) globally
- In conjunction with the Biometrician/Statistical Scientist, develop the project-level programming standards and ensure compliance with project-level/disease-area/company standards. Take leadership in supporting the CSU statistician for development of disease-area programming standards, following internal guidelines
- Ensure that documents and specifications are consistent and comply with company standards by providing input into eCRFs and data structures, tables, listings and figures for Phase I-IV clinical trials and submission activities for the responsible drug projects/program(s)
- Expert programming leadership for generation of analysis datasets, pooled datasets, listings, tables, figures, listings and Case Report Tabulations for Phase I-IV clinical trials and for regulatory submissions (e.g., SCS, SCE and RMP/safety update) and for other project support (e.g. publications and market promotion) according to established milestones. Ensure development and usage of highly efficient standard MACROs within the clinical projects/program(s)
- In consultation with the Biometrician/Statistical Scientist, responsible for development/update of project-level programming specifications of analysis datasets and pooled datasets (e.g. in MAP and CSPD) for the clinical drug projects/program(s)
- Ensure QC compliance and responsible for program records including archiving of programming and associated documentation. Responsible for quality control and audit readiness of quality programming deliverables for the drug projects/program(s)
- Mentor/coach programmers on functional expertise and process for project support across CSUs within the Franchise; Act as a programmer expert for problem-solving in programming/computing aspects within the Franchise. Act as a programmer expert within the Franchise for training and/or development of new programming applications
Qualifications and skills:
As Senior Principal Programmer, you will have the following qualifications, skills and experience:
- BA/BS/MS equivalent experience in mathematics, statistics, computer science, or health sciences
- Expert knowledge of / experience with SAS and other relevant programming software
- Proven experience in development of advanced MACROs with high programming efficiency; strong programming and problem-solving skills
- Proven experience as a strong programmer lead for clinical project(s) and submission activities (equivalent)
- Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH)
- Proven ability to effectively act as a programmer representative on non-clinical initiatives; proven ability to participate in external Pharma groups on programming related matters (e.g. CDISC)
- Work experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry (for MS Statistics / Computer Science graduates).
How to apply:
For more information or to apply for this Senior Principal Programmer position, please contact Mylene Paumier on 01438 743047 or email firstname.lastname@example.org. Please quote reference CL24310 in all correspondence.