Senior Project Biostatistics Lead- Vaccines

<p><b>Job Title: </b>Senior Project Biostatistics Lead- Vaccines</p><p><b>Location: </b>Waltham, MA</p><p></p><p><b>About the Job</b></p><p></p><p><span>Lead Biostatistician for medium complexity vaccine project (one or several indications) in clinical development and/or post-marketing stage. The incumbent is accountable for all statistical aspects of clinical development/medical affairs plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity.</span></p><p></p><p><span>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.​</span></p><p></p><p><u><span><b><span>Main Responsibilities:</span></b></span></u></p><p></p><p><span>Act as a Senior Biostatistics Expert at vaccine project level:</span></p><ul><li><p><span><span>Develop with other clinical/medical and global project team members the end-to-end clinical development plan for the vaccine;</span></span></p></li><li><p><span><span>Contribute with clinical and project team members to the internal approval of the plan by governing bodies at platform (eg: RAfS) and cross platforms level (eg: STRC, CRSF, jSRC,…)</span></span></p></li><li><ul><li><p><span><span>Propose alternative trials design options, bringing innovative approaches where it adds value with the support of the Statistical Innovation team.</span></span></p></li><li><p><span><span>Lead the cross-functional team through GO/NoGo criteria and evaluate probability of technical success.</span></span></p></li></ul></li><li><p><span><span>Contribute with project team members (ie: clinical, pharmacovigilance, regulatory,…) to gain Health Authorities acceptance of the plans, accountable from a statistical standpoint. Seek support from the Biostat Franchise Lead as needed.</span></span></p></li><li><p><span><span>Oversee for his/her project the execution of the respective clinical trials: Data capture, Randomization, Statistical Analysis Plan, Analyses deliveries for primary and secondary objectives (efficacy, immunogenicity, safety). May be in charge of the most complex/priority study in the project.</span></span></p></li><li><p><span><span>Communicate internally the trials results (Key Results Memo) and work cross-functionally (ie: clinical, safety, immunology,…) to the scientific interpretation of the results and evaluation of strategic impact on the plan.</span></span></p></li><li><p><span><span>Contribute to the external communication of the study results to Health Authorities</span></span></p></li><li><p><span><span>Accountable for the statistical aspects of the submission for marketing authorization or label improvement:</span></span></p></li><li><ul><li><p><span><span>ensure appropriate and quality data analyses are available efficiently to demonstrate the vaccine benefits-risks and support the label claims</span></span></p></li></ul></li></ul><ul><li><p><span><span>ensure quality of the clinical data CDISC packages are delivered and comply with Health Authorities (eg: FDA, PMDA, CDE, KFDA,..) expectations</span></span></p></li></ul><p></p><p><span>Act as</span></p><ul><li><p><span>Represent statistics in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards</span></p></li><li><p><span>Represent Sanofi Vaccines in cross-company activities such as consortiums or professional associations</span></p></li><li><p><span>The Senior Project Biostatistics Lead operates in a worldwide context with GBS contributors located in different sites (eg: France, US, China, India,…), with different cultures.</span></p></li><li><p><span>The Senior Project Biostatistics Lead has no direct reports but indirect ones delivering more on the operational side, requiring the incumbent to demonstrate leadership in engaging and communicating.</span></p></li></ul><p><span> </span></p><p><span><b><span>Context of the job/major challenges</span></b></span></p><ul><li><p><span>(S)He interacts with other GBS teams, Clinical, Regulatory, Global Program Head, Regulatory, Immunology, Medical Writing, Data Management</span></p></li><li><p><span>S(H)e has regular interactions with Sr R&amp;D Leaders in communicating complex statistical concepts. S(H)e represents Sanofi Vaccines for external activities.</span></p></li></ul><p></p><p><span><b><span>Dimensions/Scope</span></b></span><span> </span></p><ul><li><p><span>In his/her role of Senior Project Biostatistics Lead, the incumbent is accountable for all the biostatistics aspects related to the development, submission, launch and life cycle management of a medium vaccine project (5-7 clinical studies and global submission in key markets) or, a major vaccine program with support from the Biostatistics Franchise Lead.</span></p></li><li><p><span>The incumbent will need to lead indirectly 6-12 FTEs for delivering the different project activities. S(He) makes trade-off decision on the priorities with the global project team, where there is conflict, to ensure deliveries according to Vaccines GBU scorecards. S(He) makes decision in any cross-functional initiatives where representing the platform.</span></p></li></ul><p></p><p><span><b>About You</b></span></p><p></p><p><u><span><b>Education/experience</b></span></u></p><ul><li><p><span>Ph.D. in Biostatistics, Mathematics or related discipline is require. </span><span>Minimum 6 years biostatistics experience in pharmaceutical industry OR</span></p></li><li><p><span>MS in Biostatistics, Mathematics or related discipline is required. </span><span>Minimum 8 years biostatistics experience in pharmaceutical industry</span></p></li><li><p><span>Proven experience in clinical development or post-marketing activities</span></p></li><li><p><span>Demonstrate strong project management &amp; interpersonal skills</span></p></li><li><p><span>Broad knowledge and good understanding of advanced statistical concepts and techniques</span></p></li><li><p><span>Able to take on the asset statistical clinical aspects through regulatory interactions, submission and marketing authorization</span></p></li><li><p><span>Effective English oral and written communication skills</span></p></li></ul><p></p><p><u><span><b><span>Core Competencies</span></b></span></u></p><ul><li><p><span>Strive of Results</span></p></li><li><p><span>Act for Change &amp; Innovation</span></p></li><li><p><span>Commit to Customers</span></p></li><li><p><span>Cooperate Transversally</span></p></li><li><p><span>Thinking Strategically</span></p></li><li><p><span>Make Decisions</span></p></li></ul><p></p><p><u><span><b><span>Job Specific Competencies</span></b></span></u></p><p></p><ul><li><p><span>Scientific Rigor, Organization skills</span></p></li><li><p><span>Strategic Influencing skills</span></p></li><li><p><span>Communication and Interpersonal skills</span></p></li><li><p><span>Ability to work in a team</span></p></li><li><p><span>Computer skills (SAS, R, Office)</span></p></li></ul><p></p><p><b>Why Choose Us?</b></p><p></p><ul><li><p>Bring the miracles of science to life alongside a supportive, future-focused team.</p></li><li><p>Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.</p></li><li><p>Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.</p></li><li><p>Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.</p></li></ul><p></p><p>Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.</p><p></p><p>#GD-SP <br />#LI-SP    </p><p>#LI-Onsite<br />#vhd</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><p></p><p></p><p><i>US and Puerto Rico Residents Only</i></p><p>Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.</p><p></p><p><i>North America Applicants Only</i></p><p></p><p>The salary range for this position is:</p>$148,500.00 - $247,500.00<p></p><p>All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the <a target="_blank" href="https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid&#61;sanofi">LINK</a>.</p>