Statistical Project Leader, B&P Rare Disease and Rare Blood Disorder

Job Summary

Lead one or more indications/projects in Rare Disease or Rare Blood Disorder Therapeutic Area, under minimum supervision of senior statistical project leader or team leader.

Major Duties and Responsibilities

• Lead a project /one or several indications of a project in rare disease and rare blood disorder clinical development.

• With minimum direction from senior statistical project leader or team leader, provide statistical support and scientific leadership for responsible projects.  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 through efficient and well-managed resource allocation and across projects or areas.  Capacity to respond to unscheduled increase in project workload.

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

• Represent statistics in cross function working groups. 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.

• Broad knowledge and good understanding of advanced statistical concepts and techniques.

• Proven experience in clinical development such as submissions, interactions with regulatory agencies or other external stakeholders.

• Demonstrated strong project management, interpersonal and communication skills.

• Experience in rare diseases or rare blood disorders preferred.

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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