Associate Director, Biostatistics

Saved job description

The Associate Director, Biostatistics will function as the statistical lead on a Jazz Pharmaceuticals drug development project or as the statistical lead for individual clinical trials, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings.  This position may have direct reports.  This role is responsible for all statistical aspects of study design, study analysis and validation, and study documentation.  The Associate Director will provide timely and scientifically sound statistical expertise to clinical development projects and develop and execute statistical strategy, design, and analyses for clinical trials. The incumbent will work collaboratively with clinicians, data managers, other biostatisticians, and statistical programmers to plan, conduct, and analyze clinical studies, including integrated reporting.  Lead (if the statistical lead on a clinical development project) or support (if the statistical lead for individual clinical trials) statistical input and strategy in governance team discussions.  Contributes to or leads the development of departmental processes and procedures, including establishing standards and operating procedures.  The Associate Director will manage work done by statistics and programming external vendors.  Oversees professional development of any direct reports.

Essential Functions

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

Lead, develop and execute statistical strategy, design, and analyses for clinical trials within a project(s)

Develop or review statistical analysis plans and interpret data.

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

Contribute to or lead Biometrics teams to develop, implement, and maintain department standards and practices.

Attend meetings with regulatory agencies; respond to statistical questions from regulatory agencies.

Collaborate with researchers and thought leaders to plan clinical development projects and, if appropriate, publications of study results.

Present study results to internal and external audiences

Be able to conduct independent research and resolve statistical methodological issues

Recruit, develop and supervise internal and external statisticians.

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.

Good knowledge and experience working in Oncology therapeutic area

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

Thorough knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards.

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

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

Strong attention to detail.

Flexible, positive, creative thinker, good communicator.

Work without close supervision. Time management skills are important.

Required/Preferred Education and Licenses

PhD with > 4 years of experience or MS with > 6 years of experience

Degree in statistics, mathematics, or a related discipline with a statistical focus.

Strong knowledge of clinical trial design, sound understanding of statistical applications for clinical trials.

Expert knowledge of drug development regulations pertinent to statistical analysis.

Knowledge of the oncology or hematology therapeutic area is preferred.

Bayesian and adaptive design experience is preferred.

Experience in contributing to NDA or BLA submissions and defense.

Proficient SAS programming skills, comprehensive understanding of CDISC models and standards.

Excellent writing and communication skills, d emonstrated leadership abilities and excellent interpersonal skills

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