BioSpace · 3 days ago

Director Biostatistics

Cambridge, MA

Full-time

Onsite

Director

10+ years exp

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Comp. & Benefits

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Responsibilities

Provide leadership and guidance as the statistical expert on clinical program teams

Accountable for all statistical aspects of clinical studies and regulatory submissions

Lead statistical discussions with external parties including Health Authorities and co-development partners

Provide strategic input into program documents such as clinical development plans and target product profiles

Author/review study and program biostatistics documents (e.g., clinical study protocols, statistical analysis plans (SAP), Mock Tables, Listings, and Figures shells)

Design TLFs for study-related analyses, posters, and presentations

Oversee the activities of FSP and CRO biostatistics teams, ensuring adherence to scope of work and service agreements and that deliverables are met in accordance with study milestones/timelines and of acceptable quality.

Lead or contribute to process development, creation of biometrics standards, and development of new methodologies

Remain apprised of current or new developments and technological advancements in statistics.

Mentor/coach junior statisticians

Qualification

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Regulatory Agency InteractionsNDA/BLA/MAA SubmissionsScientific ComputingProgramming SASProgramming RProgramming PythonStatistical AnalysisData ManipulationGraphingSimulationData AnalysisRelationship BuildingIndustry Standards KnowledgeProblem-SolvingHighly MotivatedCollaborationOrganizationalLeadershipInterpersonal

Required

PhD (or MS) in Statistics or related field with 10+ (14+) years of experience in the Pharmaceutical/Biotechnology industry

Experience in preparing and participating in global regulatory agency interactions, including NDA/BLA/MAA submissions

Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing, and simulation

Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or consulting with subject matter experts

Able to build strong relationships with peers and cross-functional partners to achieve higher performance

Thorough knowledge of industry/regulatory trends and standards

Highly motivated to drive innovation by raising the bar and challenging the status quo

Demonstrate excellent collaboration, organizational/leadership abilities, and interpersonal skills