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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Director, Clinical Statistics

Job Description

Position: Director, Clinical Statistics

Role Overview

Key Responsibilities

Qualifications

What We Offer

Equal Employment Opportunity Commitment

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