Senior Director, Biostatistics
Listed on 2025-12-01
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IT/Tech
Data Scientist, Data Science Manager, Data Security, Data Analyst
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Why 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.
Why 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 strongly that you can achieve more have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
Senior Director, Biostatistics
Job Summary
The Senior Director of Biostatistics is responsible for leading the statistical activities for 1 or more clinical programs, providing strategic input on clinical development, leading statistics efforts during regulatory submissions, serving as the primary statistics point person in interactions with health authorities, and leveraging their experience to provide general input and feedback on programs in the pipeline.
Duties/Responsibilities
- Provides leadership and guidance as the statistical expert on clinical program teams while being accountable for all statistical aspects of clinical studies and regulatory submissions.
- Provides input and feedback to other programs when needed based on their experience.
- Leads statistical discussions with external parties including Health Authorities and co-development partners.
- Provides strategic input into program documents such as clinical development plans and target product profiles.
- Ensures study designs are valid, efficient, and allow for clearly interpretable results.
- Authors/reviews study and program biostatistics documents (e.g., clinical study protocols, statistical analysis plans (SAP), Mock Tables, Listings, and Figures shells).
- Designs TLFs for study-related analyses, posters, and presentations.
- Oversees the activities of FSP and CRO biostatistics teams, ensuring adherence to scope of work and service agreements and that deliverables are met in accordance with study milestones/timelines and of acceptable quality.
- Ensures deliverables are completed in a timely delivery and with high quality, including regulatory documents.
- Provides statistical support to other organizations within company in addition to Development.
- Leads complex process development efforts, creation of biometrics standards, and development of new methodologies.
- Remains apprised of current/new developments and technological advancements in statistics.
- Mentors/coaches junior statisticians.
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- Recruits, interviews, and trains new hires.
- Oversees the daily activities of direct reports and ensure accurate and timely deliverables are provided.
- Provides constructive and timely performance evaluations.
- Extensive experience in preparing and participating in global regulatory agency interactions, including NDA/BLA/MAA submissions.
- Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing, and simulation.
- Ability to identify data or analytical issues and assist with providing solutions by either applying own skills and knowledge or consulting with subject matter experts.
- Expertise in clinical trial designs and study conduct in all phases of development within relevant therapeutic areas.
- Expert in ICH GC and…
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