Statistical Project Leader, Associate Director

  • Cambridge, MA
  • Permanent
  • Full-time
  • 1 month ago
Provide leadership and guidance as the lead statistician on one or more project team(s) in late phase oncology, accountable for all methodological and statistical aspects of project(s). Act as statistical consultant within company.

Major Duties and Responsibilities

Lead one indication in late phase oncology development

With minimal direction from group head, direct statistical support and provide scientific leadership for responsible project. Accountable for statistical aspects of clinical development plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity

Mentor people working on the project. Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment. Ensure project team compliance with SOPs and departmental standards.

Plan and track project activities, 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. Effectively utilize external groups, e.g. CROs or data monitoring committees (DMC). Capacity to respond to unscheduled increase in project workload.

Provide technical guidance and mentoring to junior staff.

Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.

Represents statistics in regulatory meetings

Represent statistics to participate (and lead if applicable) in scientific or technology working groups or cross function initiatives; Contribute to operation process optimization and provide inputs to statistics standards.

Required Education/Experience:

PhD/MS in statistics or related discipline with at least 6 years of pharmaceutical experience

Demonstrated strong project/study management, interpersonal and communication skill

Broad knowledge and good understanding of advanced statistical concepts and techniques

Broad knowledge of pharmaceutical clinical development

Broad experience in clinical development or post-marketing activities such a submissions, interactions with regulatory agencies or other external stakeholders

Experience in the NSCLC desired

Ability to represent Sanofi in cross-company activities such a consortiums or professional associations

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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