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US: Director, Biostatistics

Date: 03-Dec-2015
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Director, Biostatistics

Duties & Responsibilities:

Manages resources, project priorities and timelines for assigned projects and clinical trials. Ensures optimal Biostatistics systems and processes. Perform project related tasks as required. Key participant in strategy development and contingency planning. Provides statistical expertise to Clinical Affairs staff; and determines appropriate statistical methods and procedures. Mentors Biostatistics staff. Act as key or primary contributor to FDA (and other regulatory) interactions regarding experimental design and statistical analysis. Directs the design, documentation, and implementation of complex statistical analysis methods in collaboration with Clinical Affairs and other departments. Ensures statistical methods, equipment and practices are in compliance with current regulatory regulations and guidelines. Ensures statistical integrity of tables/listings/graphs and statistical analyses that support regulatory submissions and formal organizational statements and documents such as press releases and annual reports. Maintains expertise in state-of-the-art statistical analysis techniques. Works with other project team members in Clinical Affairs to ensure CRF and database design meets analysis needs. Develops programs to perform statistical analysis and present results. Work with SAS programmers to ensure appropriate data analysis and presentation is performed. Provides input on Data Management SOPs, and develops Biostatistics SOPs and work instructions. Responsible for writing and/or reviewing Statistical Analysis Plans (SAPs), and developing table/listing/graph shells for statistical analyses and reports. Interfaces with clinical investigators and scientists to determine protocol design. Responsible for writing and/or reviewing the statistical and data analysis sections for regulatory submissions. Acts as a resource for other departments (e.g., R&D, QA, QC, Marketing, Manufacturing) regarding statistical issues including experimental design, sample size, statistical analysis and interpretation of results.


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:

Experience in leadership position within Biostatistics in the IVD (strongly preferred) industry. Successfully managed a Biostatistics staff with at least 2 direct reports. Advanced knowledge of CRF and database development, including attribute assignment and logic checking. Advanced knowledge of applicable FDA regulations and policies regarding study design, conduct, monitoring and data analysis, software program validation for database design and clinical trial data management. Advanced knowledge of statistical software packages such as SAS and/or S-Plus/R. Advanced knowledge of common and highly complex statistical theory and methods for clinical trials, design of experiment and quality control. Knowledge of business strategy, product development and risk mitigation. Knowledge of infectious disease, cancer, genomics and common public health issues. Good technical writing skills. Strong project management skills.

Education & Experience:

MS or PhD (preferred) in Biostatistics and 8-10 years of experience.

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BioTech FYI Center