Senior Director, Biostatistics

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.

Supervisory Responsibilities

☐ N/A

• 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.

Requirements

• 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 industry/regulatory trends and standards.
• Ability to build strong relationships with peers and cross-functional partners to achieve higher performance.
• Strong project management skills.                      
• Highly motivated to drive innovation by raising the bar and challenging the status quo.
• Demonstrate excellent collaboration, organizational/ leadership abilities, and interpersonal skills with the ability to clearly explain statistical considerations to non-statisticians.                           

PhD or MS in Statistics or related field

At least 12 years of experience in the Pharmaceutical/Biotechnology industry.

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.

#LI-Remote

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.