Job Information
Sanofi Group Safety Expert Statistician in Cambridge, Massachusetts
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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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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
US and Puerto Rico Residents Only
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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