1+ months

Associate Director Biometrics

West Chester, PA 19380
Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

The Associate Director, Statistics position is for a skilled statistician with training and hands on experience in drug development and clinical research.  The ideal candidate is expected to provide statistical leadership for overall program and individual study strategy within a therapeutic area. The Associate Director needs to be knowledgeable about statistical principles, appropriate software and tools to perform these tasks. An Associate Director, Statistics must be a strong individual contributor, demonstrating leadership qualities, creative and strategic thinking and knowledge of cutting-edge clinical trial design and methodology for clinical studies. This candidate must have experience with regulatory submissions both in the US and outside of the US.

 

Essential Duties & Responsibilities:         

  • Provides strategic input for study design and clinical development plan and consultation for clinical research protocols
  • Provides consultation on clinical endpoint assessments and sample size planning for clinical studies
  • Prepares, or oversees the preparation of, statistical sections of clinical protocols in collaboration with Clinical Research personnel.
  • Writes, or oversees the writing of, statistical analysis plans
  • Works with Data Management and Clinical Research personnel to provide statistical input for CRF design
  • Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts and other documents to support the marketing of CNS products
  • Ensures that data sets and their associated define files are prepared correctly and on time to support FDA submissions
  • Leads efforts to select CROs for outsourcing of statistical activities when required
Qualifications

 

  • PhD in Statistics/Biostatistics with 7+ years Pharma or FDA experience
  • Ability to program using SAS 
  • Knowledge of CDISC SDTM and ADaM
  • Knowledge of relevant FDA and CHMP guidelines
  • Ability to communicate with non-statisticians to interpret statistical findings
  • Demonstrated project and technical leadership qualities, and creative and strategic thinking

 

Experience Preferred:                   

  • Experience with regulatory submissions in the US
  • Knowledge of R
  • Demonstrated ability to deliver quality products with efficiency as well as having relevant technical and scientific publications
Function
Research & Development
Sub Function
Biometrics
Reports To

Director Statistics, SCD Statistics - US

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Categories

Posted: 2020-06-30 Expires: 2020-08-29

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Associate Director Biometrics

Teva Pharmaceuticals
West Chester, PA 19380

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