What are the responsibilities and job description for the Principal Stats Programmer (VAX) position at sanofi?
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 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: 6 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 Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.