Associate Director Biostatistics

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The Associate Director of Biostatistics will perform a variety of advanced biometrical, statistical, and technical activities for the design, analysis, and interpretation of statistical data in conjunction with a research program based on company products. They will collaborate closely with project teams consisting of clinicians, project managers, programmers, data management, and other team members. Supports (with review) trial planning and analysis activities in support of clinical trials.

Primary Responsibilities

• All statistical tasks on assigned trials including Phase I – IV clinical trials
• Establish protocol development in alignment with the development plan, statistical analysis plan, and reporting activities
• Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence
• Planning and execution of exploratory analyses and statistical consultation within cross-functional teams
• Collaborate with internal and external partners to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types
• Interact with regulatory agencies and address statistical questions and requests, including clinical investigators
• Review and/or author SOPs and/or Work Instructions related to biostatistics practices
• Contribute to external engagement with consultants, advisory boards, health authorities, congresses, and scientific meetings
• Provides statistical analyses for decision-making, regulatory submissions, and interactions with regulatory agencies
• Collaborates effectively with clinical investigators on multiple ongoing projects
• Provides statistical input into other activities and participates in interdepartmental processes
• Other duties as assigned

Education and Experience

• MS in statistics or related field; PhD preferred. An equivalent combination of relevant education and applicable job experience may be considered
• Targeting 7 years’ progressively responsible experience in clinical research with a focus on biostatistics, preferably in Clinical Research, Biotech, Pharmaceutical industry
• Knowledge and understanding of SAS programming and at least some other significant statistics software (e.g., R, S-Plus, PASS) is a plus
• Ability to code complex statistical analyses, and familiarity with good coding practices
• Solid understanding of FDA regulations, ICH GCP guidelines, and the drug development process
• Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required
• Able to prioritize work and complete deliverables to timelines with some supervision
• Demonstrate knowledge of applying sound statistical methods to various study designs
• Skilled at presenting information in a clear, concise manner to all levels within the department
• Skilled at contributing on a consistent basis to team initiatives in a detailed and timely manner
• Experience in early phase clinical trials is preferred

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.

The salary range for this role is $153,000.00 to $191,000.00. Actual amounts will vary depending on experience, performance, and location. In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance.

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