Teva Director Clinical Statistics 

United States, Pennsylvania, East Bradford Township 

491237852

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

• 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
  

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
  

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