Sanofi Group Senior Statistician Clinical Development in Swiftwater, Pennsylvania

The statistician serves as a representative of the Biostatistics platform on clinical teams and is responsible for leading the development of a product from the platform standpoint. He/she takes a leadership role in projects up to and including participation in the preparation of a dossier for submission. He/she also may represent the Biostatistics platform at external meetings with regulatory agencies and key opinion leaders.

Key accountabilities:

  • Acts as lead statistician for small to large projects, including complex designs and/or efficacy/effectiveness.

  • May participate as lead statistician in dossier submission preparation

  • Manages and follows-up the activities that are outsourced to external partners, including submissions

  • Participates and provides statistical support in the preparation of major decision-making meetings

  • Completes statistical section of the clinical study report and provides a critical review

  • Ensures accuracy of statistical methods (SAPs, sample size estimation, study design, randomization) and statistical analysis results through review and validation

  • Participates in discussions and writing of Clinical Development Plans

Basic Qualifications /Requirements:

  • Minimum of a Masters degree (Statistics , Applied Statistics, Mathematics, Data Analytics, or similar field of study) AND

  • 5+ years of experience in the pharmaceutical/biotech industry.

  • Demonstrated experience with SAS software and awareness of current features of SAS; this includes the use of SAS Base, Statistics, and Graphics.

The successful candidate will also possess the following skills:

  • Ability to work in a multidisciplinary and international team.

  • Very good oral and written communication skills.

  • Ability to lead a project(s) while providing supervision of others

  • Dossier submission experience

  • Experience providing strategic input to Study design and Clinical Development Plans

Sanofi US Services, 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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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.

Sanofi, Empowering Life

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.

Sanofi, Empowering Life