Principal Biostatistician

Locations: Shirley, NY

Job Type: Full-time

Job Family: Biostatistics

Job ID: #155594

Job Description:

The principal biostatistician serves as a senior reviewer for simple or moderately complex projects and provides additional supervision for complex or highly complex studies as needed. The principal biostatistician will supervise the statistics and programming aspects of clinical trials from design, through analysis and reporting and will lead the statistical analysis for multiple projects.

Duties and Responsibilities:

• Provide expertise in complex trial design across different therapeutic areas.
• Provide the team with expertise in the development and delivery of training materials and the implementation of departmental procedures.
• Serve as a senior reviewer.
• Serve as the lead statistician for multiple projects and lead the project team for multiple agreements.
• Interact with clients on the statistical aspects of the project and attend meetings as needed.
• Produce sample size calculations.
• Lead the development, production, validation, and review of statistical analysis plans (including tables, lists, and graph specifications).
• Specify the general structure of the analysis database, supervise its development and ensure the integrity of use in all programming.
• Supervise the preparation and quality review of statistical reports, integrated summaries of safety and efficacy, and other documents as needed.
• Advise management on recruitment, departmental policies, and resourcing requirements.
• Assist in bidding and business development activities as needed.

Qualifications:

• Master's degree (M.S./M.A.) or Ph.D. in statistics, biostatistics, mathematics, or related fields.
• Excellent understanding of statistical principles behind clinical trials.
• Excellent statistical skills.
• Excellent understanding of regulatory issues related to clinical data reporting during the submission process.
• Excellent SAS^® programming skills, familiar with other statistical software packages (such as StatXact and Nquery), and the database structure.
• Excellent organization, time management, and planning skills.
• Ability to adapt and adjust to changing priorities.
• Excellent written and verbal communication skills. Proficiency in English.
• Ability to work in a multidisciplinary team environment.
• Demonstrated initiative, motivation, and problem-solving skills.
• Ability to cooperate well with multifunctional teams and others.