Director, Statistical Programming

Location
Cambridge, MA, United States
Posted
Jun 16, 2021
Ref
R191
Hotbed
Genetown
Required Education
Bachelors Degree
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, Statistical Programming. In this role, you will collaborate closely with Biostatistics, Clinical Data Management, Clinical Operations, Drug Safety, Medical, and other functions to provide programming support 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 programming 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:

 

 

  • Develop Statistical Programming operational strategy and processes for functional work
  • Perform programming QC/validation for SDTM and ADaM datasets and Tables/Figures/Listings
  • Review specifications for SDTM and ADaM datasets as well as define.xml, reviewers guide documents and Pinnacle 21 validation reports
  • Program TFLs for study related ad hoc analyses, posters, and presentations
  • Participate in internal study team meetings as well as teleconferences with vendors and s tudy personnel
  • Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans (SAP), Mock Tables, Figures and Listings (TFL) shells
  • Participate in the creation of corporate standards, responsible for data and programming standards
  • Develop and maintain Statistical Programming SOPs
  • Mentor/coach junior statistical programmers
  • Assess performance of staff and function

 


About You:

Do you consider yourself an expert programmer, with a proven track record of strong leadership skills , and th e ability to influence at multiple levels ? Our ideal candidate will bring t horough 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, e.g., Project Orbis, CDISC, and other standards
  • Proven ability to develop staff and assess personal and function al performance
  • BS in Statistics, Computer Science, Biology, Math, Engineering or equivalent scientific field
  • 10 years of experience in the Pharmaceutical/Biotechnology industry , 7 of which in Statistics or Statistical Programming
  • Knowledge of IT infrastructure and security a plus
  • NDA/BLA/MAA s ubmission experience

 


Meet your future team:

The position reports to the Head of Biometrics a nd serves as the leader of the Statistical Programming function sitting on the Biometrics leaders hip team. In addition to these collea g u es, y our fut ure team will largely be comprised of people you bring on board - we want you to develop a shared vision with the Head of Biometrics for building the Statistical Programming function . A n entrepreneurial spirit is essential!

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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.