Job description
ABOUT THE JOB
Our Team:
At Sanofi, we have a shared commitment to bring innovation to a broad and diverse portfolio of therapeutics supported by our Biostatistics and Programming department.
You will be supported by a Biostatistics and Programming (B&P) Department that fosters people development, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients’ lives.
Main responsibilities:
Provide leadership, guidance, and strategic input as the lead statistician on a large or more complex projects in late phase. Be accountable for all statistical aspects of project(s).
In charge of all statistical inputs for submission documents, such as IND, NDA, BLA, CTE or CTD to insure statistical validity and accuracy. Act as key statistical consultant within company.
Manage transversally B&P staff working on the project. Work with stat group head about project staffing and responsible for resource planning and allocation within project B&P team. Ensure project team compliance with SOPs and departmental standards. Make sure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership, and promote team work, quality, operational efficiency and innovation.
Represents statistics in challenging regulatory meetings (ex: Advisory Committee). Provide technical guidance and mentoring to junior staff.
Represent statistics to participate (and lead if applicable) in key scientific or technology working groups or lead key cross function initiatives. Contribute to operation process optimization with senior leadership.
ABOUT YOU
Experience: 7 years or more of post-graduate experience in relevant areas
Soft skills: Strong project management, interpersonal and communication skills. Ability to represent Sanofi in major cross-company activities such a consortiums or professional associations.
Technical skills: Excellent knowledge of pharmaceutical clinical development and proven experience in late phase development such as submissions, interactions with regulatory agencies or other external stakeholders. Excellent knowledge and good understanding of advanced statistical concepts and techniques.
Education: PhD or MS in Statistics or related disciplines. PhD is preferred.
Languages: Proficient in written and spoken English
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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