About the job

- Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives.
- Ready 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 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:

- Positive 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

📌 Principal Stats Programmer (VAX) (Hyderabad)
🏢 Sanofi
📍 Hyderabad