Biostatistics Director (DR)

South San Francisco, CA - Pharmaceutical & Biotech - Remote

Date Posted: 12/22/2022 3:13:09 PM

Biostatistics Director
South San Francisco, CA - Remote

As the Biostatistics Director, you will provide statistical leadership and expertise in support of the clinical development activities for multiple therapeutic areas. You will be responsible to provide statistic contribute strategically to project decisions with a focus on pre-study planning, protocol development, sample size/power calculations, Statistical Analysis Plan preparation
eview, data quality reviews, development of tables/listings/figures, preparation/mapping of clinical study data for regulatory submission, and integrated safety and efficacy reporting. You are expected to apply innovative statistical approaches to the work; support and defend analyses and their interpretations in meetings and teleconferences with regulatory agencies and prepare written responses to agency questions. The Director will possess the ability to influence key decision-makers within the project team and within senior management to ensure a high degree of rigor to the statistical and scientific decision-making process and outcomes.

Do you want to apply your existing technical skills, join a high-performing team and learn and implement new capabilities? Can you see yourself playing a key role in clinical development and trial design for our antibody therapeutics? If so, we want to hear from you.

During your first year, your goals will include:
Define how you will contribute to the pipelines overall 3-5 year vision to continually improve our clinical development strategy. Collaborate with internal and external partners in the optimized clinical study design, end point selection and sample size calculations, analysis, interpretation, and publication of clinical trial data. Execute protocols, statistical analysis plans, study reports, ensure statistical integrity of presentations and publications of clinical studies. Support project team and clinical study team including but not limited to derivation of go/no-go criteria, generation of data visualizations and summary reports, and interpretation of results to support internal decision-making. Participate in regulatory interactions and responsible for biostatistics input into study protocols and clinical study reports. Review study randomization specifications, oversee outsourced development of analysis data and results; and reviewing case report forms while managing workflow to ensure quality, prioritization, and timeliness across multiple programs. Manage external vendors and serve as a key Biostats liaison with external organizations. Participate in establishing and maintaining policies, standards, and guidance for Biostatistical operations. Lead Biometrics & Digital Science Department Initiatives. Ensure up to date knowledge of industry and academic developments in the Neuroscience, Immuno-Oncology, and Orphan disease fields and apply to clinical study design and analysis.

Requirements:
PhD with 8-10 years, or MS with 10-12 years of proven experience in academia or industry. Pharmaceutical/biotech industry experience preferred. Solid understanding of theoretical and applied statistics. Experience with multivariate statistics and statistical methods to quantify uncertainty in multi-dimensional data; experience running simulations and mixed models. Hands-on ability to drive and lead statistical strategies for clinical development of drug candidates from first-in-human testing to all later phases of clinical investigation, including pivotal Phase 2/3 studies and NDA/BLA submissions. Demonstrated success in leading the statistical strategy, analysis, and design of a clinical development program. Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA. Advanced programming skills in in SAS and/or R and other relevant statistical software solutions. Ability to code programs to analyze and report complex clinical trial data, as well as for electronic review, exchange, transformation, and submission of data in CDlSC, SDTM and ADaM formats. Strong application of innovative study designs and developing landmark criteria (e.g. Go/No Go criteria). Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and data modeling strongly preferred.

Please contact Derek Reilly at dreilly@clarkdavis.com

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