As the Biostatistician Manager you will provide leadership with respect to specific clinical research projects and/or key functional areas within the clinical research department. These areas may include but are not limited to clinical operations, biostatistics, clinical support, project management, strategic research development, clinical post-marketing support, and regulatory support of clinical submissions. Develop clinical investigation strategy congruent with business objectives. Manage clinical study design and implementation with respect to project timelines, budgetary adherence, and personnel resource allocation.
WHAT YOU’LL DO
Clinical Trials Management
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Responsible for the design to include statistical strategy, implementation, and management of assigned clinical projects and key clinical areas as assigned.
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Provide strong clinical scientific support to clinical projects.
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Leverage appropriate internal and external expertise to successfully execute on clinical trials.
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Ensure timelines are met and budgetary constraints are adhered to.
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Continually identify and promote strategies for improved clinical research quality and best practices across the clinical research department. Proactively assess clinical project progression for early identification of issues or trends and develop strategic responses.
Clinical Data Management
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Oversee interpretation of clinical results and preparation of study summaries for regulatory submission, presentations and publications as necessary.
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Provide oversight and support to external study investigators for papers and presentations.
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Oversee investigator meetings and other public forums in which clinical data is presented or interpreted.
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Identify and access clinical research key opinion leaders to assess support for new research concepts and strategies.
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Interface with regulatory authorities directly as appropriate.
Personnel Management:
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Provide leadership to clinical research staff in alignment with company strategic goals. Manage personnel resources to appropriately support clinical project initiatives.
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Provide clear on-going guidance and support to direct reports regarding clinical research priorities.
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Monitor clinical task completion and give immediate feedback to staff on performance objectives and task completion.
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Identify and create career growth opportunities for direct reports.
Key Clinical Research Department Representative:
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Act as core team leader on cross-functional project teams as assigned.
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Proactively initiate on-going communication with other departments critical to clinical research department’s success. Such departments include but are not limited to: Marketing, Sales, Research & Development, Regulatory, and other divisional clinical research teams.
EDUCATION AND EXPERIENCE YOU’LL BRING
• M.S. in biostatistics, statistics, or related field with a minimum of 8-10 years’ experience in clinical research SAS programming; prefer at least 3 years in medical device or pharmaceutical industry clinical trials for both pre-market and post-market approval clinical trials. • Minimum 2 years’ experience with direct personnel management or project lead management. • Demonstrated expertise with data analysis tools; SAS, R or Python. • Strong interpersonal communication and presentation skills. • Strong time management, organizational, and analytical skills.