Penfield Search Partners
Contact: Mark Maurer – email@example.com
Job Description: The Director, Biostatistics is the statistical lead on one or more company drug development projects, and will act as a statistical expert across all studies in the project(s). This position can have direct reports up to Associate Director level, participates in regulatory interactions for the project(s), provides statistical leadership for direct reports, and ensures the quality and timeliness of biostatistics analyses. Contributes to or leads development of departmental processes and procedures, including establishing standards and operating procedures. Lead statistical input and strategy in governance team discussions. This position works collaboratively with clinicians, data managers, other biostatisticians, and statistical programmers in the planning, conduct, and analysis of clinical studies in all phases, including integrated reporting. Oversees professional development of biostatisticians.
- Lead drug development project(s) by developing and executing statistical strategy, design, and analyses for clinical trials.
- Manage biostatisticians within the drug development project(s).
- Manage CROs providing statistical support to ensure timely delivery of quality analysis results; oversee contracts and invoices.
- Approve guidelines and standards of CROs to ensure quality of deliverables.
- Contribute to or lead Biometrics teams to develop, implement, and maintain department standards and practices.
- Provide technical support and input to project statisticians and statistical tasks.
- Provide statistical expertise to prepare for meetings with regulatory agencies; attend meetings with regulatory agencies; respond to statistical questions from regulatory agencies and support and defend clinical programs.
- Collaborate with researchers and thought leaders in the planning of clinical development programs and the publication of study data.
- Present study results to internal and external audiences.
- Develop statistical programs as necessary to simulate clinical trial design operating characteristics, simulate clinical trial design operating characteristics, perform analysis, prepare data displays, and verify the correctness of data and analyses.
- Be able to conduct independent research and resolve statistical methodological issues.
- Recruit, develop, and supervise internal and external statisticians to achieve project goals.
- May lead outsourcing statistical activities within a program.
Required Knowledge, Skills, and Abilities:
- Expert 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 or R; knowledge of other statistical applications and programming languages a plus.
- Expert 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 with a view to bring studies to a quality conclusion.
- Flexible, positive, creative thinker, good communicator.
- Work without close supervision. Well-developed time management skills are important.
- PhD or MS degree in statistics, mathematics, or a related discipline with a statistical focus.
- A minimum of 8 years of experience; supervisory experience is preferred.
- Expert knowledge of drug development regulations pertinent to statistical analysis.
- Knowledge of the oncology or hematology therapeutic are is preferred.
- Bayesian and adaptive design experience.
- Experience in contributing to NDA or BLA submissions and defense is required.
- Proficient SAS programming skills, solid understanding of CDISC models and standards.
- Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.