Principal Stats Programmer (VAX)

Main responsibilities:

• Plan and execute high quality and timely statistical programming deliverables in the context of a vaccine project
• At study level for various analyses within a study:
  • Review and provide feedback on study documents (e.g.: protocol statistical section, Case Report Form, Statistical Analysis Plan (SAP)); create mock TLFs
  • Write and provide the programming specifications for the SDTM/ADaM/TLFs to fulfil the study or project objectives
  • Deliver compliant CDISC data package with all relevant documentation (ie: aCRF, reviewers guide, define.xml) fulfilling Heath Authorities expectations
• At project level for various analyses within an asset:
  • Review and provide feedback on integrated analysis plan and create mock TLFs
  • Create core integrated clinical database, pooling SDTM/ADaM across several studies for different reporting purposes like ISS/ISE/ISI, DSUR, PBRER or safety surveillance
• Ensure TLF??s format fulfil the requirements of targeted publishing (i.e.: clinical study report, publication, Transparency like Eudract, CTT.gov, lay summaries,...)
• Take leadership, guiding more junior staff and ensuring quality and timely deliveries
• Perform quality control for statistical programming deliverables and complete the associated documentation: Validation plan and quality control (QC) documentation.
• Propose and Program exploratory and/or post??hoc analyses based on problem statement
• Ensure compliance to SOP's, standards, and guidelines.

About you

You are a passionate leader with following experience and competences who like the challenge and growing into a new environment:

• Experience:
  • 8+ years experience in statistical programming clinical research with some Vaccines experience (designs, endpoints, statistical methods, ?)
  • SAS (>3 years): excellent technical skills in BASE, STAT, MACRO, GRAPH, SQL, R, and familiar in statistical programming
  • Experience programming CDISC SDTM/ADaM datasets and notably vaccines specifics (including writing specifications, P21, proficiency with controlled terminology, value-level metadata, analysis results metadata, define.xml, Reviewers Guide)
  • Experience in providing solutions for complex programming issues (including creation of complex macros), presenting alternatives and identifying the best solution
  • Experience pooling data from multiple studies according to existing specifications
  • Experience planning and drafting specifications for pooling data from multiple studies
  • Consistent successful experience as a lead on several concurrent studies/projects
  • e-submission preparation experience strongly preferred

• Skills:
  • Good understanding of processes associated with clinical trials
  • Ability to independently create specifications
  • Knowledge of descriptive statistics
  • Demonstrate interpersonal skills necessary for effective teamwork
  • Demonstrate ability to organize multiple work assignments and establish priorities
  • Demonstrate critical thinking skills beyond simply following directions or specifications
  • Ability to lead complex and large tasks, demonstration of strong project management skills

• Education:
  • Bachelors or Masters degree in Statistics, Mathematics, Computer Science or related health sciences or equivalent experience
• Languages:
  • English: Highly effective communication, both oral and written