Director Biostatistics

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+) years of experience in the Pharmaceutical/Biotechnology industry.

• 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.

• 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                                

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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.