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    Director, Clinical Statistics

    Teva Pharmaceuticals
    8 years
    Not Disclosed
    West Chester
    10 Nov. 21, 2024
    Job Description
    Job Type: Full Time Education: Ph.D./MS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Who We Are
    At Teva Pharmaceuticals, we are on a mission to make good health more affordable and accessible, enabling millions worldwide to lead healthier lives. This mission unites our team across nearly 60 countries, embracing diverse nationalities and backgrounds. As the world’s leading manufacturer of generic medicines and a proud producer of many products on the World Health Organization’s Essential Medicines List, we impact over 200 million lives every day.

    While this is a remarkable achievement, we are constantly seeking innovative ways to expand our impact and welcome talented individuals to join us in making a difference.

    Position: Director, Clinical Statistics

    Location: West Chester, PA (onsite 3 days per week)
    Travel Requirements: Medium

    Role Overview

    The Director, Clinical Statistics will play a pivotal role in providing statistical leadership and strategic direction in clinical development, regulatory strategy, and medical affairs. With deep expertise in statistical principles and innovative trial methodologies, the Director will support the development of therapies across multiple disease areas, shaping strategies and influencing cross-functional teams.

    This role may function as an individual contributor or as a manager with direct reports, mentoring junior statisticians and fostering professional growth.

    Key Responsibilities

    Strategic Leadership

    • Provide strategic and scientific guidance for clinical development, registration strategy, and interactions with health authorities.
    • Influence clinical trial designs and statistical methodologies to optimize program success.
    • Act as a strategic business partner involved in high-level organizational decisions.

    Program Oversight

    • Lead statistical input for clinical development plans across multiple diseases/indications.
    • Collaborate with cross-functional teams (clinical, regulatory, market access) to drive data-driven decisions.
    • Represent Teva at external scientific forums and industry events.

    Team & Resource Management

    • Oversee direct reports, contingent workers, and vendors, ensuring quality and timeliness of deliverables.
    • Mentor and guide statisticians, fostering professional development and growth.
    • Manage budgets, resource allocation, and training needs.

    Operational Contributions

    • Prepare or oversee statistical sections of clinical protocols.
    • Ensure adherence to ICH, FDA, and CHMP guidelines.
    • Contribute to due diligence activities for potential acquisitions or partnerships.

    Qualifications

    Education

    • Ph.D. or MS in Statistics, Biostatistics, or a related field.
    • MS with a minimum of 8 years of experience or Ph.D. with a minimum of 6 years of experience.

    Technical Expertise

    • Proficient in statistical software (e.g., SAS, JMP; knowledge of R is a plus).
    • Expertise in surrogate biomarker development and validation in early-phase clinical studies.
    • In-depth knowledge of therapeutic areas and competitive landscapes.

    Skills

    • Strong leadership, communication, and problem-solving abilities.
    • Ability to mentor, inspire, and manage cross-functional teams.
    • Experience with regulatory submissions (US and international).

    What We Offer

    Teva provides a comprehensive benefits package, including:

    • Health Coverage: Medical, Dental, Vision, and Prescription coverage starting on Day 1.
    • Financial Benefits: 6% 401(k) match, Employee Stock Purchase Plan, and Tuition Assistance.
    • Time Off: Paid Time Off, 13 paid holidays, and more.
    • Additional Perks: Disability and Life Insurance.

    Equal Employment Opportunity Commitment

    Teva Pharmaceuticals is committed to creating a diverse and inclusive workplace. We provide equal employment opportunities without regard to age, race, religion, gender, disability, sexual orientation, veteran status, or any other legally protected status.

    Accommodation Requests
    If you require accommodations during the recruitment process, please inform us. Your information will remain confidential and used solely to ensure an accessible experience.

    Application Process
    If you’re a current Teva employee, please apply via the internal career site accessible on "Employee Central."

    Note for Recruitment Agencies
    Teva does not accept unsolicited resumes from agencies. Resumes submitted without a valid agreement will become Teva’s property, and no fees will be paid.

    Join us in shaping the future of healthcare and making a difference in millions of lives worldwide.

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