myGwork - LGBTQ+ Business Community · 2 days ago

Director Biostatistics

Collegeville, PA

Full-time

Onsite

Director

$162K/yr - $269K/yr

10+ years exp

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Responsibilities

Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and registration projects.

Provide planning and communication of statistical analyses, data presentations and scientific reports, including clinical trial results, exploratory analyses and analyses that synthesize results across studies, support for publication activities, scientific presentations and support for product defense.

Be accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects. Ensure that all statistics activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.

Develop effective collaborations with colleagues within clinical teams, partner lines of other functioning areas, and external regulatory, industry and professional and academic organizations.

Provide statistical input and leadership to cross-functional activities - collaborate with other statisticians, study managers, alliance partner colleagues - for assigned studies and regulatory submissions.

Provide input to the Senior Director of Statistics to plan support for assigned studies and submissions.

Participate in research on statistical methodology and its applications pertinent to Pfizer's business needs.

Qualification

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Clinical TrialsRegulatory OperationsMarketing OperationsStatistical LeadershipStatistical SkillsMathematical CalculationsData AnalysisEffective CommunicationCollaborationVaccine Research

Required

PhD or MS in statistics, biostatistics or related field with at least 10 years' experience in clinical research and development, including at least 2 years management (direct or matrix) experience

Relevant clinical trial and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations

Capability to provide statistical leadership to cross-functional teams at the protocol and project level

Strong statistical skills with application to clinical trials

Effective verbal and written communication skills in collaborating with colleagues and associates both inside and outside the organization

Providing statistical support and oversight for one or more clinical projects

Ability to perform mathematical and statistical calculations

Ability to perform complex data analysis