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 - E xperience 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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