Study Statistician, Global Medical Affairs and Data Sciences, Bridgewater, NJ

Job description

Responsibilities:

Act as statistician on a product project team or within a Business Unit for Medical Affairs. With general guidance from the Biostatistics Medical Affairs and Data Sciences project lead statistician, provide statistical support to study designs and execution. Coordinate the activity of external statisticians working on the project to develop Statistical Analysis Plans and perform other tasks including sample size calculations, leading statistical aspects for data review and surveillance, table mockups and analysis specifications, data analysis and reporting. Be able to advise on analytic strategies and recommend methodological solutions appropriate for late phase research.

Provide statistical representation at Medical Affairs meetings. Build relationships with other Medical Affairs' functions to effectively collaborate on activities that may involve real world elements. Learn key clinical and life cycle management considerations, to ensure that planned statistical methods are applicable and optimal, and communicate statistical perspective to stakeholders.

In some cases incumbent could serve as a subject matter expert in the area of Medical Affairs such as in observational methods, or real world study designs. Additional responsibilities may include hands-on statistical programming for data mining of existing clinical databases, to provide strategic and timely analytic support for abstract and manuscript development and submissions to medical/scientific congresses or publications, and to provide analytic support for internal and external communications and statistical interpretations of data under the guidance of departmental methodological principles.

Requirements:

*Thorough knowledge of pharmaceutical clinical development, together with Late Phase experience. Potential to serve as statistical consultant for Late Phase activities, based on strong understanding of statistical methods appropriate for Medical Affairs.

*Solid level of proficiency in statistical analysis and demonstrated knowledge of current developments in Real World Evidence (RWE) methodologies.

*Experience managing CROs and consultant groups.

*Excellent work ethic. Should be able to work on multiple assignments concurrently and should have excellent communication skills.

*Masters or PhD degree in statistics or related discipline with approximately 5 or 3 years of pharmaceutical experience respectively, with at least 1 year in the Medical Affairs area.

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.

#GD-SA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.