Senior Statistical Programmer - Clinical Research and Vaccine Data

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 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:

• • 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

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• Languages:

• • English: Highly effective communication, both oral and written

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Experience Level

Senior Level