SUMMARY: Provides statistical direction and support for the design, analysis, and reporting of clinical studies.
ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to):
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.
Identifies appropriate, efficient experimental designs, defines analysis endpoints, develops randomization plans, and determines 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 statistical analyses and programming to ensure that timelines are met, resource issues are identified and resolved, and all applicable data and programming standards are adhered to.
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, data standards, and selection and implementation of statistical software.
Assumes a leadership role in terms of at least one clinical program, with the responsibility of ensuring that the statistical requirements are met for all projects in the program.
Performs independent research as needed and explores, develops, and implements new statistical methods for the analysis of clinical study data.
Demonstrated experience in the design, analysis, and reporting of clinical studies.
Strong working knowledge of the SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data.
Hands-on experience working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets.
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.
Must be able to travel up to 5% of the time per year. Requires the ability to sit or stand while working on a PC for long periods of time.
EDUCATION and/or EXPERIENCE:
MS or PhD in statistics or biostatistics, or a related discipline, with a minimum of 3 year’s relevant experience or equivalent education and experience.