Sanofi
Healthcare
PrincipalStatisticalProgrammer(VAX)
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“Principal Statistical Programmer (VAX) at Sanofi. Skills: SAS, CDISC, Statistical programming, Data pooling. Plan and execute statistical programming deliverables. Review and provide feedback on study documents”
What You'll Achieve.
Delivering biostatistics and programming activities; Fulfilling study or project objectives; Fulfilling Heath Authorities expectations; Ensuring quality and timely deliveries
Industry & Context.
Providing solutions for complex programming issues; Identifying the best solution; Critical thinking skills
What They're Looking For.
Must Have
6+ years experience in statistical programming clinical research, SAS (>3 years), Experience programming CDISC SDTM/ADaM datasets, Experience in providing solutions for complex programming issues, 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, 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
Nice to Have
some Vaccines experience, familiar in statistical programming, vaccines specifics (including writing specifications, P21, proficiency with controlled terminology, value-level metadata, analysis results metadata, define.xml, Reviewers Guide), e-submission preparation experience
What You'll Do.
Plan and execute statistical programming deliverables
Review and provide feedback on study documents
Write programming specifications for SDTM/ADaM/TLFs
Deliver compliant CDISC data package
Review and provide feedback on integrated analysis plan
Create core integrated clinical database
Ensure TLF's format fulfil publishing requirements
Perform quality control for statistical programming deliverables
Propose and Program exploratory analyses
Ensure compliance to SOP's
How You'll Work.
Team & Collaboration
Guiding more junior staff; Interpersonal skills necessary for effective teamwork
Process & Methodology
Ability to lead complex and large tasks, Demonstration of project management skills, Organize multiple work assignments and establish priorities
Full Job Description
External Job Description As a **Principal Statistical Programmer** within our Hyderabad Hub, you’ll be part of a performing team, delivering biostatistics and programming activities throughout the Vaccines R&D value chain (Pre-Clinical, Clinical, Translational, CMC) with our Vaccines Global Biostatistical Sciences team. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. **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
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