Sanofi
Senior Project Biostatistics Lead- Vaccines
Sanofi, Waltham, Massachusetts, United States, 02254
* Develop with other clinical/medical and global project team members the end-to-end clinical development plan for the vaccine;* 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,…)* + Propose alternative trials design options, bringing innovative approaches where it adds value with the support of the Statistical Innovation team.
+ Lead the cross-functional team through GO/NoGo criteria and evaluate probability of technical success.* 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.* 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.* 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.* Contribute to the external communication of the study results to Health Authorities* Accountable for the statistical aspects of the submission for marketing authorization or label improvement:* + ensure appropriate and quality data analyses are available efficiently to demonstrate the vaccine benefits-risks and support the label claims* Represent statistics in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards* Represent Sanofi Vaccines in cross-company activities such as consortiums or professional associations* 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.* 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.* 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.* 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.* Proven experience in clinical development or post-marketing activities* Demonstrate strong project management & interpersonal skills* Broad knowledge and good understanding of advanced statistical concepts and techniques* Able to take on the asset statistical clinical aspects through regulatory interactions, submission and marketing authorization* Effective English oral and written communication skillsPh.D. in Biostatistics, Mathematics or related discipline is require. Minimum 6 years biostatistics experience in pharmaceutical industry ORMS in Biostatistics, Mathematics or related discipline is required. Minimum 8 years biostatistics experience in pharmaceutical industry* Scientific Rigor, Organization skills* Strategic Influencing skills* Communication and Interpersonal skills* Ability to work in a team* Computer skills (SAS, R, Office)* Bring the miracles of science to life alongside a supportive, future-focused team.* Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.* 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. #J-18808-Ljbffr
+ Lead the cross-functional team through GO/NoGo criteria and evaluate probability of technical success.* 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.* 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.* 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.* Contribute to the external communication of the study results to Health Authorities* Accountable for the statistical aspects of the submission for marketing authorization or label improvement:* + ensure appropriate and quality data analyses are available efficiently to demonstrate the vaccine benefits-risks and support the label claims* Represent statistics in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards* Represent Sanofi Vaccines in cross-company activities such as consortiums or professional associations* 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.* 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.* 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.* 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.* Proven experience in clinical development or post-marketing activities* Demonstrate strong project management & interpersonal skills* Broad knowledge and good understanding of advanced statistical concepts and techniques* Able to take on the asset statistical clinical aspects through regulatory interactions, submission and marketing authorization* Effective English oral and written communication skillsPh.D. in Biostatistics, Mathematics or related discipline is require. Minimum 6 years biostatistics experience in pharmaceutical industry ORMS in Biostatistics, Mathematics or related discipline is required. Minimum 8 years biostatistics experience in pharmaceutical industry* Scientific Rigor, Organization skills* Strategic Influencing skills* Communication and Interpersonal skills* Ability to work in a team* Computer skills (SAS, R, Office)* Bring the miracles of science to life alongside a supportive, future-focused team.* Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.* 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. #J-18808-Ljbffr