Sanofi Group Senior Manager, Biostatistics in United States

Overview

In this role you will assume responsibility for methodological and statistical aspects of a complex late phase study or group of clinical studies in oncology, with general direction from Therapeutic Area Head/Deputy (TAH/TAD). Provide leadership and guidance on statistical matters to interdepartmental clinical/regulator teams.

Major Duties and Responsibilities

  • With general guidance from senior departmental staff, support one or more clinical trial teams (CTT) for all relevant statistical matters. Act as direct liaison to the CTT or provide guidance to a junior staff member filling this role. Develop one or more key protocols for a specific project. Work with clinical and regulatory functions to define study endpoints and perform relevant sample size calculations. Effectively utilize external groups, e.g. CROs or data monitoring committees (DMC). Develop statistical analysis plan (SAP).

  • Provide general guidance on definition and documentation of derived variables needed to produce planned tables, listings, and graphs (TLG). Assume responsibility for accuracy of derived variables.

  • Oversee execution of the statistical analysis according to the SAP and preparation of the statistical methods and results sections for the clinical study report (CSR). Provide statistical insight into interpretation and discussion of study results. Facilitate review and approval of CSR.

  • Produce / coordinate production of statistical summaries, analyses, annual reports (INDAR), and related materials for submission to regulatory authorities or to independent monitoring committees. Review submission documents, such as IND, NDA, CTE, or CTD to insure statistical validity and accuracy.

  • Collaborate with project team to create the clinical development plan (CDP). Work with senior departmental staff to develop statistical positions on key study or project issues. Act as departmental representative to extended project team.

  • Provide significant input to TAH/TAD on project activity and timeline tracking, resource planning, and preparation of scientific reports or position papers.

  • Provide technical guidance and mentoring to junior staff. Integrate corporate values into working practices.

Required Education/Experience

  • Ph.D./MS in statistics or related discipline with 5+/7+ years of pharmaceutical experience

  • Knowledge of pharmaceutical clinical development

  • Ability to use statistical methods to assess/improve efficiency and decision process in drug development

  • Expertise and some practical experience in use of advanced statistical methodologies, especially with application to clinical trial design and analysis

  • Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices, e.g., CTD guidance, ICH guidelines

  • Basic understanding of key clinical and regulatory concepts, endpoints, and trial designs in one or more therapeutic areas / indications, preferably in oncology

  • Understanding of other functional areas and ability to maintain productive inter-function working relationships

  • Familiarity with design, production, and use of submission-quality electronic datasets

  • Ability to define and meet study / project timelines for deliverables such as protocol, clinical study summaries, and key analyses

  • Demonstrated high level of productivity and efficiency

  • Strong communication skills

  • Ability to organize, lead, and motivate teams

Preferred Experience

  • Active research interest in area directly related to drug development

  • Presentation skills

  • Involvement with societies or committees relevant to drug development or statistics

  • Team-leader and negotiation skills

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