Director Biostatistics

Location
Cambridge, MA
Posted
Oct 08, 2021
Ref
R270
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
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 want all of our 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:

We are looking to hire a Director, Biostatistics. In this role, you will collaborate closely with Statistical Programming, Clinical Data Management, Clinical Operations, Drug Safety, Medical, and other functions to provide Biostatistical leadership and influence the clinical development process. You will support the Head of Biometrics by participating on the Biometrics Leadership Team and leading process improvement workstreams. You will oversee the activities of FSP and CRO biostatistics teams to ensure adherence to scope of work and service agreements and to ensure deliverables are met in accordance with study milestones/timelines and with quality. Other key responsibilities include: 

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

  • Oversee biostatistics function resourcing approaches.

  • Design clinical trials using novel methodologies

  • Lead statistical discussions with external parties including Health Authorities and Co-Development partners.

  • Develop analysis and reporting standards for all clinical trials

  • Review specifications for SDTM and ADaM datasets, as well as define.xml, reviewers guide documents, and Pinnacle 21 validation reports

  • Design TLFs for study-related planned and ad hoc analyses, posters, and presentations

  • Participate in internal program and study team meetings, including teleconferences with vendors and study personnel

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

  • Lead Biostatistical activities for global marketing authorizations

  • Participate in the creation of corporate standards

  • Support the Discovery organization via statistical consulting

  • Develop and maintain Biostatistical SOPs

  • Mentor/coach junior statisticians

About You:

Are you curious about cutting-edge science, with a proven track record of strong leadership skills, and the ability to influence at multiple levels? Are you motivated and excited by the idea of helping to build a department?  Our ideal candidate will bring a thorough knowledge of the clinical development process (from development, launch, through life cycle management). A broad understanding of the responsibilities of other functions will be also required (e.g., Regulatory, Regulatory Operations, Clinical Operations, Data Management, Drug/Patient Safety, etc.). Other key skills include: 

  • Thorough knowledge of industry/regulatory trends and standards

  • Proven ability to develop staff and assess personal and functional performance

  • PhD in Statistics or related field

  • 10+ years of experience in the Pharmaceutical/Biotechnology industry

  • NDA/BLA/MAA submission experience 

  

Meet your future team:

The position reports to the Head of Biometrics and will sit on the Biometrics leadership team.    You will oversee functional service providers and help establish the long-run vision of the organization.  An entrepreneurial spirit is essential!

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Covid-19 Vaccination Policy: Effective Monday, January 3, 2022, all Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. Requests for exemption for medical or sincerely held religious beliefs will be considered.

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.