Principal Stats Programmer (VAX)

<p>As a <b>Principal Statistical Programmer </b>within our Hyderabad Hub, you’ll be part of a performing team, delivering biostatistics and programming activities throughout the Vaccines R&amp;D value chain (Pre-Clinical, Clinical, Translational, CMC) with our Vaccines Global Biostatistical Sciences team.</p><p><span> </span></p><p>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.</p><p><span> </span></p><p><b><span>Main responsibilities:</span></b></p><p><span> </span></p><ul><li><p><span>Plan and execute high quality and timely statistical programming deliverables in the context of a vaccine project</span></p></li><li><p><span>At study level for various analyses within a study:</span></p></li><li><p><span>Review and provide feedback on study documents (e.g.: protocol statistical section, Case Report Form, Statistical Analysis Plan (SAP)); create mock TLFs</span></p></li><li><span>Write and provide the programming specifications for the SDTM/ADaM/TLFs to fulfil the study or project objectives</span></li><li><span>Deliver compliant CDISC data package with all relevant documentation (ie: aCRF, reviewers guide, define.xml) fulfilling Heath Authorities expectations</span></li></ul><p></p><p><b><span>At project level for various analyses within an asset:</span></b></p><ul><li><span>Review and provide feedback on integrated analysis plan and create mock TLFs</span></li><li><span>Create core integrated clinical database, pooling SDTM/ADaM across several studies for different reporting purposes like ISS/ISE/ISI, DSUR, PBRER or safety surveillance</span></li><li><span>Ensure TLF’s format fulfil the requirements of targeted publishing (i.e.: clinical study report, publication, Transparency like Eudract, CTT.gov, lay summaries,...)</span></li><li><span>Take leadership, guiding more junior staff and ensuring quality and timely deliveries</span></li><li><span>Perform quality control for statistical programming deliverables and complete the associated documentation: Validation plan and quality control (QC) documentation.</span></li><li><span>Propose and Program exploratory and/or post’hoc analyses based on problem statement</span></li><li><span>Ensure compliance to SOP&#39;s, standards, and guidelines.</span></li></ul><p></p><p><i><b><span>About you</span></b></i></p><p><br /><span>You are a passionate leader with following experience and competences who like the challenge and growing into a new environment:</span></p><p></p><p><b><span>Experience</span></b><span>:</span></p><ul><li><span>6&#43; years experience in statistical programming clinical research with some Vaccines experience (designs, endpoints, statistical methods, …)</span></li><li><span>SAS (&gt;3 years): excellent technical skills in BASE, STAT, MACRO, GRAPH, SQL, R, and familiar in statistical programming</span></li><li><span>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)</span></li><li><span>Experience in providing solutions for complex programming issues (including creation of complex macros), presenting alternatives and identifying the best solution</span></li><li><span>Experience pooling data from multiple studies according to existing specifications</span></li><li><span>Experience planning and drafting specifications for pooling data from multiple studies</span></li><li><span>Consistent successful experience as a lead on several concurrent studies/projects</span></li><li><span>e-submission preparation experience strongly preferred</span></li></ul><p></p><p><b><span>Skills</span></b><span>:</span></p><ul><li><span>Good understanding of processes associated with clinical trials</span></li><li><span>Ability to independently create specifications</span></li><li><span>Knowledge of descriptive statistics</span></li><li><span>Demonstrate interpersonal skills necessary for effective teamwork</span></li><li><span>Demonstrate ability to organize multiple work assignments and establish priorities</span></li><li><span>Demonstrate critical thinking skills beyond simply following directions or specifications</span></li><li><span>Ability to lead complex and large tasks, demonstration of strong project management skills</span></li></ul><p></p><p><b><span>Education</span></b><span>:</span></p><ul><li></li></ul><p><span>Bachelors or Masters degree in Statistics, Mathematics, Computer Science or related health sciences or equivalent experience</span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1>Pursue <i>progress</i>, discover <i>extraordinary</i></h1><p>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.</p><p></p><p>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.</p><p></p><p>Watch our <a href="https://www.youtube.com/watch?v&#61;SkpDBZ-CJKw&amp;t&#61;67s" target="_blank">ALL IN video</a> and check out our Diversity Equity and Inclusion actions at <a href="https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness" target="_blank">sanofi.com</a>!</p>