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
