Provides a leadership role in providing biostatistical support for the design, analysis, and reporting of clinical studies in one or more clinical program areas.
Collaborates with Clinical Development and Medical Writing project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study reports.
Selects the optimal experimental designs, defines endpoints, develops randomization plans, and identifies and/or develops appropriate statistical methods of analysis for clinical studies.
Reviews and approves clinical study database data validation specifications, data review plans, coding guidelines, and data transfer agreements.
Prepares, reviews, and approves statistical analysis plans.
Works closely with statistical programmers to ensure that statistical methods are implemented correctly in statistical programs and collaborates with programmers in developing formats and specifications for summary tables, figures, and listings.
Oversees and monitors CRO performance of biostatistics as needed to ensure that timelines are met and that resource issues are identified and resolved. Provides biostatistical support to nonclinical areas of the company, including consulting and statistical analysis.
Assists in the development of department standard operating procedures and statistical analysis plan and report templates, and selection and implementation of statistical software.
Assumes a leadership role in terms of at least one clinical program area, with the responsibility of ensuring that the statistical requirements are met for all projects in the program area, and performs independent research as needed and explores, develops, and implements new statistical methods for the analysis of clinical study data.
Significant experience in the design, analysis, and reporting of clinical studies.
Strong SAS programming skills required, and a thorough understanding of data management processes is essential.
Thorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data. Experience in interacting directly with regulatory authorities highly desirable.
Excellent oral and written communication skills are required.
EDUCATION and/or EXPERIENCE:
MS or PhD in statistics or biostatistics, or a related discipline, with a minimum of 8 years relevant experience or equivalent education and experience.