Director, Statistics

Teva Pharmaceutical Industries Malvern , PA 19355

Posted 2 months ago

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

Overview

The Director, Statistics position is for a skilled statistician with training and significant experience in drug development and clinical research. He or she is expected to provide statistical leadership for overall program and individual study strategy for multiple therapeutic areas within clinical research and development from phases 1-4. He or she needs to be an expert in statistical principles and appropriate software and tools to perform his or her tasks. A Director, Statistics must be a strong individual contributor and a dynamic leader within the organization possessing creative and strategic thinking and knowledge of cutting-edge complex, innovative clinical trial design and methodology for all phases of clinical development. He or she must have experience with regulatory submissions both in the US and outside of the US. He or she must have excellent written and oral communication skills and must be willing to lead and mentor clinical statisticians within their team. This position will be located in Frazer, PA or Netanya, IL.

Responsibilities include but are not limited to:

Providing strategic and scientific leadership to the entire clinical development process, registration strategy, submission, health authority interactions, and medical affairs/market access plans for complex programs across therapeutic areas. He/she must be an organizational leader that is a key contributor in defining and driving the line function strategy.

The Director will lead and optimize the contribution from the team(s) by collaborating and consulting with Research/Development/Medical Affairs/Market Access partners, exhibiting a comprehensive understanding of drug development and associated operational requirements whilst demonstrating modern, enterprise, global leadership skills. They are a key contributor to the decision making governance for Teva.

  • Strategic and/or managerial responsibilities for Biostatistics across multiple programs/ indications of Teva. Lead (large) therapeutic areas and accountable for the statistical input and influence for the programs for themselves and their direct reports (Clinical Development Plan: CDP, dose-finding, regulatory strategy, publication, pricing/market access).

  • A modern drug development global leader operate as a full partner to clinical and scientific leadership. Ensure effective partnership with other functions including clinical, regulatory and other strategic functions to drive quantitative decision sciences / making in drug development and enable successful impact on CDPs, programs and trials.

  • Interact and manage KOLs/CROs and represents the company in external scientific and industry forums.

  • Is seen as a strategic Business partner involved in high-level decisions having an impact on the organization globally.

  • Leading clinical development and global statistics through the use of novel/innovative clinical trial designs and statistical methodology

  • Becomes proficient in the knowledge of the therapeutic area and competitive landscape of the specified therapeutic areas

  • 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

  • Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts and other documents to support the marketing of CNS products

Qualifications

  • Ph.D. in Statistics/Biostatistics (or related field) with a minimum of 10 years of related experience

  • Excellent presentation and written communications skills.

  • Expert in the planning, analysis and reporting of clinical trials with a strong knowledge of complex, innovative trials

  • Ability to communicate with non-statisticians to interpret statistical findings

  • Good organizational and problem-solving skills.

  • Demonstrated project and technical leadership qualities, and creative and strategic thinking required.

  • Excited and willing to manage and mentor statisticians within a team

  • Ability to program using SAS, knowledge of R is beneficial

  • Knowledge of CDISC SDTM and ADaM

  • Knowledge of relevant FDA and CHMP guidelines

  • Experience with regulatory submissions in the US

  • Experience with regulatory submissions outside the US

  • Demonstrated ability to deliver quality products with efficiency as well as having relevant technical and scientific publications is preferred.

  • Provides thought leading perspective into the external/ competitive environment and internal partner interface.

Function

Research & Development

Sub Function

Biometrics

Reports To

Teva's Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Nearest Major Market: Philadelphia


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Director, Statistics

Teva Pharmaceutical Industries