Jobs for People with MS: National MS Society

Job Title: Statistical Project Lead - Biomarker

Location : Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The Statistical Biomarker Leader is involved in the clinical development process from early on to lead the statistical aspects of the biomarker discussions as part of the clinical project team and is responsible for generation actionable data-driven insights from clinical biomarkers to optimize targeted patient population and increase the productivity of drug development in one or more therapeutic areas (e.g., oncology, immunology & inflammation, neurology, rare disease, and rare blood disorders).

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Lead in multiple complex projects / one or several indications of a project in clinical development phases with regard to statistical activities in Precision Medicine and Biomarker activities.

• Leverage biomarker data/evidence from different sources (e.g., pre-clinical data, RWE, publications) and provide appropriate input for the development of the biomarker strategy of a clinical project in collaboration with project team members.

• Implement innovative data analytical tools (e.g., AI, machine learning) and statistical methodologies to transform the complex biomarker data into insights that can be readily used in drug development.

• Planning, analyzing, and reporting of various of biomarker data (e.g., biomarker profiles, genome-wide datasets, medical imaging data, continuous data from wearable devices) collected from clinical studies for both formal reporting and exploratory analyses purposes.

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

• Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment.

• 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 project team compliance with SOPs and departmental standards.

• Represents statistics in regulatory discussions and meetings for biomarker topics

• Represent statistics to participate (and lead if applicable) in scientific or technology working groups or cross-functional initiatives

• Provide technical guidance and mentoring to junior staff.

About You

• PhD/MS in statistics or related discipline with a minimum of 6 years of pharmaceutical experience

• Demonstrated strong study management, interpersonal and communication skills

• Broad knowledge and good understanding of advanced statistical concepts and techniques in various biomarker data collected in clinical studies

• General knowledge of pharmaceutical clinical development and the process of clinical decision making; experience of using biomarker data in clinical decision-making process is desired

• Broad Biomarker knowledge

• Proven experience in clinical development, interactions with regulatory agencies or other external stakeholders is desired

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

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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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, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

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. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)