Senior Statistical Programmer VAX

Main Responsibilities

• Perform programming activities for all statistical deliverables (i.e.: SDTM, ADaM, Tables Listings and Figures (TLF)) for various analyses within a study (e.g.: interim/final analyses, internal or external data monitoring committees, statistical surveillance) or within a project (i.e.: ISS, ISE, ISI, DSUR, PBRER,…)
• Review and provide feedback on study documents, such as protocol (statistical section), Case Report Form (CRF), Statistical Analysis Plan (SAP) and 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
• Ensure TLF’s format fulfil the requirements of targeted publishing (i.e.: clinical study report, publication, Transparency like Eudract, CTT.gov, lay summaries,...)
• Perform quality control for statistical programming deliverables and complete the associated documentation: Validation plan and quality control (QC) documentation.
• Program exploratory and/or post’hoc analyses with minimum specifications
• Create core integrated clinical database, pooling SDTM/ADaM datasets across several studies within an asset
• Ensure compliance to SOPs, standards, and guidelines.
  
  

• Experience:
• 5-7 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 pooling data from multiple studies according to existing specifications
• Experience planning and drafting specifications for pooling data from multiple studies
  
  

• 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
  
  

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