Associate Director, Biostatistics

Associate Director, Biostatistics

Job Purpose

The Associate Director will provide statistical leadership and technical expertise in support of postmarketing and clinical development activities for multiple therapeutic areas.

The Associate Director will be responsible to provide strategic and tactical statistical leadership to projectlevel decisions with a focus on overall clinical program development and strategy, pre-study planning, protocol development, sample size/power calculations, Statistical Analysis Plan preparation/review, data quality reviews and development of tables/listings/figures, preparation/mapping of clinical study data for regulatory submission, and integrated safety and efficacy reporting.

The Associate Director is encouraged to apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and /or Bayesian approaches), support and defend statistical analyses and their interpretations in regulatory agency interactions; author statistical contributions to clinical study reports, regulatory briefing documents and NDA submissions.

The Associate Director will partner with cross-functional project teams and other Biometrics functions to meet project deliverables in a timely and scientifically sound manner.

Duties and Responsibilities

The duties and responsibilities include but are not limited to the following:

Build partnership with stakeholders within Clinical Development; participate in and support the design, planning and execution of Clinical Development activities such as protocol, statistical analysis plan, reporting and interpretation of clinical study results, and regulatory interactions; · Actively participate in project teams as the Biostatistics lead. Interacts strategically with crossfunctional teams and other functional areas to ensure timely project deliverables; · Maintains consistently high performance standards and quality of work and ensures all clinical development programs meet scientific, regulatory, quality and commercialization requirements; · Provide statistical expertise in the clinical development and lifecycle management activities for all assigned products; · Plans, directs and organizes all statistical activities for the assigned products including study protocol development, statistical methodology, data analysis and interpretation, and ensures clinical trials are optimally designed, properly analyzed and clearly presented to support new product development, regulatory submissions and the maintenance and growth of existing products
· Collaborate with the head of Biometrics and other project statisticians so that activities are aligned with company goals; standards and processes are consistent across all therapeutic areas; · Lead in development and adaptation of new statistical methodology in support of drug development; · Participate in establishing and maintaining policies, standards and guidance for Biostatistical operations; · Lead Biometrics Department Initiatives; · Manage outside statistical CROs and consultants, as needed, maintaining a constant and open communication to make sure timely and quality deliverables.

Qualifications · A PhD in statistics or biostatistics with minimum 8 years of clinical development experience in the pharmaceutical/biotech industry. · Experience with regulatory interactions (FDA and/or EMA). · Solid understanding of clinical trial principles and regulatory requirements. · Knowledge of industry data standards. · Proficiency with statistical analysis software such as SAS and/or R. · Effective verbal and written communication and strong interpersonal skills. · Demonstrated ability to work in a team environment. · Must be flexible and work well within a dynamic, interdisciplinary, small company environment requiring multi-tasking and changing priorities. · Dynamic self-starter; agile learner; strategic and creative thinker. · Proven ability to work under minimal supervision. · Demonstrated strong problem solving and risk-mitigation skills.

Direct Reports This position does not have any direct reports at the present time. It is expected that this position will be highly effective at managing and coordinating Biometrics efforts within the assigned projects for the purposes of achieving project goals.