Senior Principal Programmer – Basel (Switzerland)

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.

Responsibilities:

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). 

Mylene Paumier - Biometrics Recruitment Consultant at CK Clinical

How to apply:

Apply online now:

For more information or to apply for this Senior Principal Programmer position, please contact Mylene Paumier on 01438 743047 or email mpaumier@ckclinical.co.uk. Please quote reference CL24310 in all correspondence.

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