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Head of Global Biostatistics & Medical Writing

Date: Nov 24, 2022

Location: Philadelphia, US, 1111

Company: Teva Pharmaceuticals

Who are we?

Together, we are on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds.

Working here means working as part of the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we are always looking for new ways to continue making a difference, and new people to make a difference with.

Job Description

The VP, Head of Global Biostatistics & Medical Writing is responsible for creating and implementing the strategic direction for biostatistics, real world evidence, programming, data management and eData collection activities across all projects, in all phases of development and ensuring that proper statistical analyses and interpretations are carried out.  S/he will be responsible for developing functional infrastructure and biometrics capabilities at Teva and, in collaboration with the Heads of Clinical Development & Regulatory Science, set the long-term strategic direction for Biometrics in-line with the broader Development strategy.  The VP, Head of Global Biostatistics & Medical Writing will be a key contributor to the long-term planning for the Development organization and directly accountable for key milestone that support corporate objectives.

VP, Head of Global Biostatistics & Medical Writing will lead and develop the organization for the future, as well as implement disciplined financial and project management systems and processes. The successful candidate will need to make tough choices regarding prioritization of projects and manage budgetary and time commitments. They will be accountable for building a compliant, effective and efficient Statistics & Biometrics organization which collaborates and aligns with global teams.

This role directs and supports Teva’s activities to ensure effective, compliant & timely clinical development, submission, review and approval of Teva’s sponsored global regulatory applications. It is responsible for resourcing and managing Teva’s organization that consists of the initial core development functions in the near term: Data Monitoring and Management, Statistical Programming and Analytics, Statistics.

The incumbent will lead the Statistics & Biometrics Leadership Team comprised of leaders of the core development functions. The accountability is by working closely with the organization as well as global business units to align on goals & objectives.

Key Responsibilities

  • Full accountability for the organization, including compliance with local & global SOPs & regulations and has an active role in its oversight.
  • Drive strategic direction for development in Teva, and builds a “Best in Class” organization.
  • Manage governance bodies for the organization (e.g. Compliance Committee) working collaboratively with Teva’s line functions.
  • Develop next generation of leaders to ensure pipeline ready to assume greater leadership of the organization in future.
  • Accountable for consistent implementation and standards across the portfolio.
  • Ensure collaboration with global development leads in the planning and execution of global clinical trials.
  • Establishes and maintains relationships broadly inside of Teva’s global organization.
  • Where applicable, accountable for quality & timeliness of global regulatory submissions in alignment with globally endorsed strategy/program.
  • Accountable for maintaining close ties with global BUs development organization to assure alignment of activities & with global line heads to assure adaptation of best practices.
  • Updates global functions on any significant operational, regulatory or compliance related matters that impact Teva’s reputation &/or relationship with regulators.
  • Establishes & maintains broad relationships outside of Teva: ensures a close working relationship with academia and CROs.
  • Ensures an ongoing influential role in the external R&D community.
  • Be an industry leader driving initiatives within Teva & other cross industry organizations.

Qualifications

Education & Knowledge Requirements:

  • 15+ years of experience in pharmaceutical, biotech, medical device industry or equivalent; global experience strongly preferred
  • Masters or PhD in statistics or related field
  • 5+ years of experience leading a statistical or biometrics function
  • Demonstrated experience in early clinical development
  • Experience with regulatory agencies; prior record of regulatory approvals preferred
  • Prior people management experience and experience identifying organizational needs (talent, process, technology) is required
  • Demonstrated managerial & development skills to identify and rapidly develop talent to assume leadership roles
  • Experience managing both internal and contracted resources to effectively manage and execute development programs
  • Experience as both a line manager & team leader in a matrix organization
  • Demonstrated experience in being able to work across cultural lines
  • Demonstrated experience collaborating across a large organization with demonstrated ability to integrate technical & commercial needs both on a global and local basis

 

 

Function

Research & Development

Sub Function

Biometrics

Reports To

Executive Vice President, Global R&D and CMO, Global R&D Management - US

Competencies

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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, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.