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Director Biostatistics

Job Description

Job Summary
Provide leadership and guidance as the lead statistician on one or more project team(s) in Neuroscience, accountable for statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity.  Act as key statistical consultant within company.  Responsible for project staffing, resource planning and allocation within project team(s).


Major Duties and Responsibilities

  • Lead large or complex late phase project(s) / multiple indications of a large late phase project(s). Represent stat leadership in cross function working groups. Provide insights to innovative statistical application and operation strategies
  • Mentor people working on the project.  Promote teamwork, quality, and innovation. Create productive work environment.  Ensure project team compliance with SOPs and departmental standards.
  • Direct statistical support and provide scientific leadership for one or more projects of clinical development.  Accountable for statistical aspects of clinical studies and submissions of the project(s).
  • 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.  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.

Required Education/Experience:

  • PhD/MS in statistics or related discipline with at least 8-10 years of pharmaceutical experience
  • Demonstrated leadership, project management, and interpersonal/communication skill
  • Broad knowledge and superior understanding of advanced statistical concepts and techniques
  • Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development
  • Experience in neuroscience clinical trials preferred but not required

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.


#GD-GZ
#LI-GZ
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

Job Requirements

 

Job Snapshot

Location US-MA-Cambridge
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type
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Company Overview

Sanofi

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference on patients’ daily life, wherever they live and enable them to enjoy a healthier life. Learn More

Contact Information

US-MA-Cambridge
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Snapshot
Sanofi
Company:
US-MA-Cambridge
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Store Type:

Job Description

Job Summary
Provide leadership and guidance as the lead statistician on one or more project team(s) in Neuroscience, accountable for statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity.  Act as key statistical consultant within company.  Responsible for project staffing, resource planning and allocation within project team(s).


Major Duties and Responsibilities

  • Lead large or complex late phase project(s) / multiple indications of a large late phase project(s). Represent stat leadership in cross function working groups. Provide insights to innovative statistical application and operation strategies
  • Mentor people working on the project.  Promote teamwork, quality, and innovation. Create productive work environment.  Ensure project team compliance with SOPs and departmental standards.
  • Direct statistical support and provide scientific leadership for one or more projects of clinical development.  Accountable for statistical aspects of clinical studies and submissions of the project(s).
  • 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.  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.

Required Education/Experience:

  • PhD/MS in statistics or related discipline with at least 8-10 years of pharmaceutical experience
  • Demonstrated leadership, project management, and interpersonal/communication skill
  • Broad knowledge and superior understanding of advanced statistical concepts and techniques
  • Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development
  • Experience in neuroscience clinical trials preferred but not required

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.


#GD-GZ
#LI-GZ
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

Job Requirements

 
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Director Biostatistics Apply now