Director Biostatistics

Posted 19 Hours Ago
Be an Early Applicant
Hiring Remotely in Massachusetts
Remote
Senior level
Biotech
The Role
As the Director of Biostatistics, you will lead statistical aspects of clinical studies, provide guidance on regulatory submissions, and collaborate with external partners. You will mentor junior statisticians and oversee biostatistics team activities, ensuring quality deliverables. The role requires strategic input into clinical development documents and advanced statistical analysis using scientific computing.
Summary Generated by Built In

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:

  • 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                                

#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.

Top Skills

Python
R
SAS
The Company
HQ: Cambridge, MA
668 Employees
On-site Workplace
Year Founded: 2014

What We Do

Intellia Therapeutics is a leading genome editing company whose mission is to develop potentially curative gene editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

We are focused on the development of proprietary therapeutics using a recently developed biological tool known as the CRISPR/Cas9 system. The promise of the CRISPR/Cas9 system is the driving force behind the creation of Intellia. Our founders have a shared belief that the CRISPR/Cas9 technology has the potential to transform medicine by permanently editing disease-associated genes in the human body with a single treatment course. This technology offers the potential for us to develop curative therapeutic options for patients with chronic diseases by addressing the underlying cause of the disease. It can bring new hope and cures to people who now have nowhere to turn for help.

Our combination of deep scientific expertise and clinical development experience, along with our leading intellectual property portfolio, puts Intellia in a unique position to unlock broad therapeutic applications of the CRISPR/Cas9 technology and create a new class of therapeutic products. Intellia has the right people, assets and ambitious vision needed to take full advantage of the CRISPR/Cas9 technology’s attributes – high potency, specificity, simplicity of use, broad applicability, and multifunctional programmability – and accelerate the advancement of curative products into the clinic.

View our social media community guidelines at https://www.intelliatx.com/terms-and-conditions/

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