Associate Director, Biostatistics
📋 Role Overview & Responsibilities
Innovative Biotech in the DC/Maryland/Virginia area is seeking a "rising star" in Biostatistics to lead out several integral studies in rare and neurological indications. Take on the opportunity to grow your leadership skills, and hone your knowledge in advanced statistical methodology.
Day-to-Day
Develop the team as a lead statistician by performing on multiple projects across different therapeutic areas. Oversee and manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician and programming team in support of biostatistics operational activities.Participate study related activities and provide statistical consultation, input and guidance to cross-functional groups Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others.Support the development and execution of regulatory documents and submissions Contribute to clinical trial design, protocol development and Clinical Study Report (CSR)Work as biostatistics function representative in clinical projects and studies. Participate in - and at times - lead out the study meetings and project updatesSupport and participate activities related to regulatory requests and meetings as needed. Close communication with functional manager is expected.Deliver statistical insights and consultations by identifying potential issues, providing recommendations and bring in statistical experts external for relevant issues as needed.
Qualifications· 5 years Biostatistics of experience working in industry clinical trials · Ph.D. in Biostatistics or other mathematical discipline · Applied experience with statistical programming languages including SAS and R· Strong ability to communicate, both verbally and written
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This position is located in Rockville, MD with potential relocation and sponsorship assistance depending on candidate qualifications.
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