Safety Expert Statistician

About the Job:

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Biostatistics team as a Safety Expert Statistician and you'll be supporting our V division with your safety data analysis talents to support safety monitoring teams.

Job Summary

Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and statistical aspects for safety data analyses around pooled clinical trial data of project(s).  Act as statistical consultant within company for safety analyses, also on individual trial level.  

Major Duties and Responsibilities

• Lead safety signal detection, validation, charaterisation and reporting for several projects with minimal direction from group head, direct statistical support and provide statistical scientific leadership for clinical trial safety data within a project.  Accountable for statistical aspects for safety analysis, including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity.

• Accountable for all safety statistical deliverables for complex projects

• Promote teamwork, quality, operational efficiency, and innovation.  Ensure safety monitoring team compliance with SOPs and departmental standards.

• Plan and track project activities related to safety, timelines, and resource use.  Provide justification for planned resource needs.  Seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas. . Capacity to respond to unscheduled increase in workload.

• Lead discussion around definition and harmonization of quality standards also on individual trial level within and across therapeutic areas.

• Provide technical guidance and mentoring to junior staff.

• Ensure productive collaborations with other functions in the safety monitoring team and with other statistics project leaders and in communicating with senior leadership.

• Represent statistics to participate (and lead if applicable) in scientific or technology working groups or cross function initiatives. Contribute to operation process optimization. Develop, promote state-of-the-art methodology and standards for safety analyses.

About you:

• PhD/MS in statistics or related discipline with 6 years of pharmaceutical experience Knowledge of epidemiology methods and concepts in safety context

• Demonstrated strong project/study management, interpersonal and communication skills

• Broad knowledge and good understanding of advanced statistical concepts and techniques, including bayesian methodology

• Broad experience in clinical development or post-marketing activities such a submissions, interactions with regulatory agencies or other external stakeholders

• Experience safety signal detection desired

• Ability to represent Sanofi in cross-company activities such a consortiums or professional associations

• Ability and mindset to embrace change, innovate and continuously improve practice  

Why Choose Us?

• 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.

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.

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