BioSpace · 3 days ago

Assoc Director, Biostatistics

Bridgewater, NJ

Full-time

Hybrid

Director

$147K/yr - $206K/yr

10+ years exp

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Comp. & Benefits

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Responsibilities

Lead complex clinical trials or indication corresponding to one or several compounds in development.

Represents Biostatistics as a member of cross-functional teams, accountable for statistical aspects of statistical design, study setup, execution, analysis, and reporting of clinical trials.

Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams.

Undertake new and highly complex issues requiring advanced analytical thought with minimal supervision.

Support global submission deliverables as needed including responses to health authority queries, advisory committee meeting preparation, etc.

Provide statistical support for the Biometrics Department's infrastructure needs.

Qualification

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Pharmaceutical Environment KnowledgeRegulatory Requirements KnowledgeAdvanced Statistical ConceptsClinical Research KnowledgeProject ManagementInterpersonal SkillsCommunication SkillsNDAsMAAsStatistical MethodologyInfluenceProblem-Solving

Required

MS in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience or a PhD in Statistics/Biostatistics with more than 6 years of relevant pharmaceutical experience

Knowledge of pharmaceutical environment and regulatory requirements

Comprehensive knowledge and understanding of advanced statistical concepts and techniques applicable to Clinical Research

Excellent project management, interpersonal and communication skills