Brief Description:

The Principal Statistician, Biostatistics will be a lead statistician supporting the design and reporting of Phase I to IV clinical studies and support regulatory filings under the supervision of a more senior statistician.  This role is responsible for the statistical aspects of study design, study analysis and validation, and study documentation.  The Principal Statistician will provide timely and scientifically sound statistical expertise to clinical trials and develop and execute statistical strategy, design, and analyses for clinical trials.  This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.  The Principal Statistician will oversee work done by statistics and programming external vendors

Essential Functions

• Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.

• Work collaboratively with members of study teams to meet study and recurring report timelines.

• Support the development and implementation of study protocols.

• Review and provide input to study-specific data capture systems and participate in their validation.

• Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming.

• Write statistical analysis plans, perform data analysis and validation, and interpret analyses.

• Support project lead statistician.

• Prepare for and attend meetings with regulatory agencies.

• Respond to statistical questions from regulatory agencies.

• Work closely with statistical programming colleagues.

• Monitor CRO guidelines and standards to ensure timeliness and quality of deliverables.

• Review and validate CRO deliverables.

• Other work as assigned by line manager.

• Collaborate as the statistical subject matter expert with medical writers in the production of clinical reports, integrated summaries, and other documents.

• Learn drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards.

• Stay current with new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and other professional development activities.

Required Knowledge, Skills, and Abilities

• Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis.

• Experience in using SAS and R; knowledge of other statistical applications and programming languages a plus.

• Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines.

• Able to work in a fast-paced, flexible, team-oriented environment.

• Possess excellent interpersonal and communication skills (written and verbal).

• Strong attention to detail with a view to bring studies to a quality conclusion.

• Flexible, positive, creative thinker, good communicator.

• Be able to work without close supervision with effective time management.

Required/Preferred Education and Licenses

• MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in pharmaceutical or biotechnology industry.

• PhD in statistics, mathematics, or a related discipline with a statistical focus and < 2 years of experience in the pharmaceutical or biotechnology industry.

• Knowledge of drug development regulations pertinent to statistical analysis.

• Bayesian and adaptive design knowledge is preferred.

• Proficient SAS & R programming skills, understanding of CDISC models and standards.

• Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.

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