Director, Clinical Statistics
West Chester, United States, Pennsylvania, 19380
Who we are
The opportunity
The Director, Clinical Statistics is a skilled statistician with significant experience in drug development and clinical research, including regulatory interactions both inside and outside of the US. They are expected to provide a high level of statistical leadership within Global Statistics and Data Sciences by providing clinical development support for one or more compounds within a disease indication or across an entire therapeutic area. In this role, the Director will provide strategic thinking that impacts the clinical development program as well as at the study design and analysis level. They are highly knowledgeable with respect to statistical principles, engaged with innovative clinical trial methodology, and experienced with appropriate software and tools. They must have excellent communication skills, both written and oral, and be able to effectively influence cross-functional teams. In this role, they will have a significant impact on drug development programs and have visibility with senior level management.
A Director, Clinical Statistics may be an individual contributor or have direct management responsibilities.
• As an individual contributor, they must demonstrate leadership and impact across the entire department and individual development programs. In addition, they will serve as a mentor to help guide and develop statisticians at the Associate Director level and below.
• As a manager, they must provide clear guidance to their direct reports on interacting with cross-functional teams with respect to assigned projects. In addition, they are expected to support professional development of their direct reports.
Travel Requirements: Medium
The person hired will need to work onsite 3 days a week out of our West Chester, PA location
How you’ll spend your day
- Provides strategic and scientific leadership to the clinical development, registration strategy, submission, health authority interactions, and medical affairs/market access plans for complex programs across multiple diseases
- Organizational leader that is a key contributor in defining and driving the line function strategy
- Leads and optimizes the contribution from the team(s) by collaborating and consulting with key partners, exhibiting a comprehensive understanding of drug development and associated operational requirements whilst demonstrating modern, enterprise, global leadership skills
- Strategic and/or managerial responsibilities for Global Statistics across multiple programs/indications of Teva. Independently lead (large) programs and accountable for the statistical input and influence for the programs (Clinical Development Plan: manufacturing, pre-clinical, 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. Ensures 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
- Interacts and manages 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
- Leads 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 area
- Prepares, or oversees the preparation of, statistical sections of clinical protocols in collaboration with Clinical Research personnel
- Supports due diligence activities
- Forecasts and maintains budgets
- Primarily works at the TA / Functional Level
- Likely to have direct reports; Oversee contingent workers and/or vendors; Provide training to others; Strategically analyze needs to manage resources and accountable for resource allocation
- Accountable for delivering assignments with quality and within timelines
Your experience and qualifications
Education Required:
- Ph.D./MS in Statistics/Biostatistics (or related field)
- MS with a minimum of 8 years of related experience; PhD with a minimum of 6 years of related experience
Specialized or Technical Knowledge Licenses, Certifications needed:
- Development and validation of surrogate biomarkers in early phase clinical studies.
Functional Knowledge:
- strategic and statistical leadership to department, complex clinical studies or programs across multiple diseases. Knowledge of the therapeutic area and competitive landscape of the specified therapeutic area. Lead statistics and clinical development through the use of innovative clinical trial designs and statistical methodology.
Job Specific Competencies:
- Formulates strategy under guided supervision; Demonstrates ability to both differentiate and determine optimal strategies.
- Tackles complex problems; Makes independent decisions using analysis to drive solutions
- Persuade and inspire team to take action; Expert negotiation skills; lead process development and improvement cross-functionally
- Excellent presentation and written communications skills
- Expert in the planning, analysis and reporting of clinical trials
- Ability to communicate with non-statisticians to interpret statistical findings
- Experience working in an outsourcing model (fully or functional outsourcing)
- Good organizational and problem-solving skills
- Demonstrated project and technical leadership qualities, and creative and strategic thinking required
- Demonstrated ability to deliver quality products with efficiency as well as having relevant technical and scientific publications is preferred
- Ability to supervise staff directly while exhibiting emotional intelligence. Also, able to recognize need for corrective action regarding their direct report's performance and behaviors and take timely action as necessary.
- Ability to program using SAS or JMP, knowledge of R is beneficial
- Provides thought leading perspective into the external/ competitive environment and internal partner interface.
- Knowledge of relevant ICH, FDA and CHMP guidelines
- Experience with regulatory submissions in and outside of the US
Enjoy a more rewarding choice
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
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.
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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
