Biostatistics - Director

Location: Bridgewater, NJ, United States
Date Posted: 04-19-2016
Our client - a $30B global healthcare organization is seeking a Statistical Expert to manage clinical studies for a particular therapeutic area.  Opportunity to work from home two days a week.

Act as key statistical consultant within company. Responsible for project staffing, resource planning and allocation within therapeutic area(s). Responsible for facilitating career development of direct reports and assisting Department Head with creation and implementation of policies. May have regional or global management responsibility.

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.

Ideal Candidate

PH.D. (MS) in statistics or related discipline.
10+ (12+) years of pharmaceutical experience, including significant interactions with regulatory bodies, history of successful management (4+ years), and expertise in one or more therapeutic areas (ANY)
In-depth understanding of the regulatory drug submission / approval process regionally and globally
Experience managing direct reports, assembling teams, and implementing working relationships with external agencies, such as CRO, consultant groups, and research committees
Knowledge of regulatory laws / procedures outside of US and Europe
Leadership role in societies or committees relevant to drug development or statistics
Ability to contribute to advancement of statistical or applied specialized area of knowledge
Contact information:
Max Populi, LLC
4628 Bayard Street, #207
Pittsburgh, PA 15213-2750
Tel: (412) 567-5279
Fax: (412) 567-5198
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