- Serve as the biostatistics leader in multiple clinical development teams responsible for determining clinical study strategies and manage teams to deliver results with high quality and on time
- Champion in bringing innovative statistical thinking and methods to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programs
- Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types
- Oversee development of statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses
- Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence
- Frequently interact with regulatory agencies and effectively address the statistical questions and requests
- Review and/or author SOPs and/or Work Instructions related to biostatistics practices
- Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
- Oversee statistical contractors / consultants and manage / mentor junior team members
- PhD (or equivalent degree) with 9+ (for Director) of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. MS (or equivalent degree) with 12+ years of relevant experience.
- Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems. Experience in Rare Diseases therapeutics clinical development is preferred.
- Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
- Experience working on oncology, vaccine/infectious disease and rare disease clinical studies and regulatory interactions are preferred.
- Experience working with clinical safety, independent unblinded statistician is preferred.
- Experience working with CROs, vendors, and relationship management preferred.
- Outstanding communication skills (verbal and written).
- Ability to manage multiple projects in a fast-paced environment.
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
- Vacation, sick time and holidays
- Volunteer time to participate within your community
- Discretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras
-
Director, Biostatistics
2 weeks ago
Biogen Cambridge, United StatesJob Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or my programs ...
-
Director, Biostatistics
2 weeks ago
Biogen Cambridge, United StatesJob Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or my progra ...
-
Director, Biostatistics
1 week ago
Biogen Cambridge, United StatesAbout This Role This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or m Director, Development, Clinica ...
-
Director, Biostatistics
2 weeks ago
Biogen Cambridge, United StatesJob Description · Job DescriptionJob Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and a ...
-
Director Biostatistics
2 weeks ago
Green Key Resources Boston, United StatesJob Description · Job DescriptionThe Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development program(s). He/she is responsible for statistical activities including: designing innovative clinical trials, authoring statistic ...
-
Director, Biostatistics
2 weeks ago
Rhythm Pharmaceuticals Boston, United States Full time· Company Overview · Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide m ...
-
Director, Biostatistics
4 weeks ago
Editas Medicine Cambridge, United StatesAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...
-
Director Biostatistics
1 week ago
Intellia Therapeutics, Inc. Cambridge, United StatesWhy Join Intellia? · Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. · Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel str ...
-
Director, Biostatistics
2 weeks ago
Bristol-Myers Squibb Somerville, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to ...
-
Director, Biostatistics
2 days ago
Deciphera Pharmaceuticals Watertown, United StatesCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise ...
-
Director Biostatistics
3 weeks ago
Birdseye Partners Waltham, United StatesAssociate Director / Director - Biostatistics · Our client is seeking a Associate Director/Director, Biostatistics to join their growing team. This person will be responsible to lead, develop, and implement statistical analyses to support the early development clinical trials, su ...
-
Director, Biostatistics
3 weeks ago
Biogen Cambridge, United StatesJob Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or my programs ...
-
Director, Biostatistics
2 weeks ago
Biogen Idec Cambridge, United StatesJob Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or my program ...
-
Associate Director, Biostatistics
3 weeks ago
Sarepta Therapeutics Cambridge, United StatesAssociate Director, Biostatistics page is loaded · Associate Director, Biostatistics · Apply · remote type · Remote · locations · Cambridge, MA · time type · Full time · posted on · Posted 4 Days Ago · job requisition id · R-02253 · The person in this position will b ...
-
Director, Biostatistics
3 weeks ago
Editas Medicine Cambridge, United StatesAt Editas, were driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRIS ...
-
Associate Director, Biostatistics
2 days ago
Sarepta Therapeutics Cambridge, United StatesThe person in this position will be working with a cross functional team as the project biostatistician responsible for statistical activities at the compound level or study level for one or more Gene therapy programs. It is an excellent opportunity to work at the forefront of pr ...
-
Director Biostatistics
3 weeks ago
Intellia Therapeutics, Inc. Cambridge, United StatesWhy Join Intellia? · Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. · Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel stro ...
-
Director, Biostatistics
2 weeks ago
Bristol-Myers Squibb Somerville, MA, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line t ...
-
Associate Director, Biostatistics
1 day ago
Alexion Pharmaceuticals Boston, United States Full timeThis is what you will do: · The Associate Director, Biostatistics has sufficient experience working as a statistician in the pharmaceutical industry to independently perform and lead statistical work within a project, an indication within a more complex project. This individual ...
-
Associate Director, Biostatistics
1 week ago
Pfizer Cambridge, United StatesWHY PATIENTS NEED YOU · Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. W ...
Director, Biostatistics - Cambridge, United States - Moderna Theraputics
Description
The Role:
This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry.
Here's What You'll Do:
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.
Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit to learn more about our current opportunities.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society.
We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at (EEO/AAP Employer)#LI-JL3
#J-18808-Ljbffr