$155,000 - $195,000
Doctor of Philosophy
Jan 09, 2017
A terrific opportunity to provide leadership and guidance as the statistical expert on a project team within a therapeutic area for a Fortune 100 Drug development company.
You will be accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. You will act as key statistical consultant within company.
Additional Responsibilities will include project staffing, resource planning and allocation, facilitating career development of team members and assisting Group Manager with creation and implementation of policies.
This role may include regional or global management responsibility as well.
Major challenges involve design of statistical and operational approaches that will meet future regulatory needs. Key collaborators are external leaders and key staff in other disciplines.
Oversee statistical support to multiple project teams.
Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and producing individual protocols. Work independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project.
Statistically valid CDP involving one or more studies designed to lead to a key decision point or submission. CDP, related protocols, and statistical analysis plans (SAP) consistent with overall project objectives. CDPs have degree of optimality in terms of timing, use of resources, and probability of success.
Oversee execution of statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries.
PH.D. (MS) in statistics or related discipline with 10+ (12+) years of pharmaceutical experience, including significant interactions with regulatory bodies, history of successful management (4+ years),
Experience managing direct reports, assembling teams, and implementing working relationships with external agencies, such as CRO, consultant groups, and research committees;
Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management;
Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development;
In-depth understanding of the regulatory drug submission / approval process regionally and globally;
Knowledge of regulatory laws / procedures outside of US and Europe;
Leadership role in societies or committees relevant to drug development or statistics;