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Director Biostatistics

4 months ago

Cambridge, United States Intellia Therapeutics Full time

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 at Intellia. We 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.

How You Will Achieve More With Intellia:

Provide leadership and guidance as the statistical expert on clinical program teams

Accountable for all statistical aspects of clinical studies and regulatory submissions

Lead statistical discussions with external parties including Health Authorities and co-development partners

Provide strategic input into program documents such as clinical development plans and target product profiles

Author/review study and program biostatistics documents (e.g., clinical study protocols, statistical analysis plans (SAP), Mock Tables, Listings, and Figures shells)

Design TLFs for study-related analyses, posters, and presentations

Oversee 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.

Lead or contribute to process development, creation of biometrics standards, and development of new methodologies

Remain apprised of current or new developments and technological advancements in statistics.

Mentor/coach junior statisticians

About You:

PhD (or MS) in Statistics or related field with 10+ (14+) yearsofexperience in the Pharmaceutical/Biotechnology industry.

Experience in preparing and participating in global regulatory agency interactions, including NDA/BLA/MAAsubmissions

Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing, and simulation.

Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or consulting with subject matter experts

Able to build strong relationships with peers and cross-functional partners to achieve higher performance

Thorough knowledge of industry/regulatory trends and standards

Highly motivated to drive innovation by raising the bar and challenging the status quo

Demonstrate excellent collaboration, organizational/ leadership abilities, and interpersonal skills

#LI-KO2

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.