Westat is seeking a Senior Biostatistician to join the Clinical Trials Practice Group. This role will provide leadership for the robust application of traditional and emerging statistical methodologies for the development and execution of regulated clinical trials. You will work closely with a team that includes regulatory affairs, client scientific staff, clinical operations development and medical monitors to ensure Westat statistical analysis plans satisfy study objectives, and that the analyses are completed on time and with high quality. This multi-faceted role will have you overseeing the development of statistical content of clinical documentation, representing biostatistics on various sub-teams and/or other appropriate forums, as well as serving as a primary point-of-contact for biostatistics questions and fielding inquiries regarding clinical research studies. You will also provide biostatistics inputs for study data reporting including medical publications.
Roles and Responsibilities • Have strong strategic, statistical and clinical skills, and can apply appropriate strategies and techniques in a wide variety of situations, especially those required for the design, conduct and analysis clinical trial; • Be familiar with current innovative trial design, such as adaptive design, and analysis methods; • Effectively communicate statistical concepts to non-statistical audiences (e.g., medical science, clinical, regulatory affairs, and medical affairs colleagues); • Understand the regulatory environment for development of drugs and biologics in the United States, Europe, and other jurisdictions, and can author responses and other documents for regulatory agencies and contribute to preparation and execution of meetings with regulators; • Have experience in clinical trial design, including issues related to blinding and bias minimization; • Have familiarity with SAS or other software statistical packages as needed; • Have experience working in and resolving conflict in cross-functional teams; • Understand drug development issues common to other functions (eg clinical operations, regulatory affairs) and work to achieve solutions that balance the needs of both biostatistics and the other groups; • Be able to author protocol statistical sections, SAPs, and results and methods sections of clinical study reports and manuscripts; • Have excellent project management skills (including management of vendor/CRO outsourced work). • Be able to provide strategic and technical input into clinical development plans; • Be able to manage multiple projects/tasks, people, and can appropriately prioritize such tasks; • Show a strategic interest in the competitive environment for products being developed.
Westat offers competitive benefits with ESOP, 401k, Health, Dental, paid vacation, sick and holiday leave, professional development as well as other benefits.
Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the position, based on the specific position which may include, for example, identity verification, employment history, or criminal records history.
Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity, or any other protected status under applicable law.
Basic Qualifications: • A Ph.D. in statistics, biostatistics, or related field with at least 10 years of experience in clinical trials, or MS in statistics, biostatistics, or related field with 15 years of experience in clinical trials. • Must have experience interacting with drug development regulatory agencies (e.g., FDA and/or EMA). • Scientific and organizational leadership experience.
Additional Salary Information: Benefits include: 401k, ESOP, Health, Dental, Vision, Disability Ins, Critical Illness Ins, Flex Accounts, Vacation Leave, Sick Leave, Holiday Pay and Professional Development support.
Internal Number: 15289BR
Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.