Principal Statistician Oncology with Submission Experience

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

Job Responsibilities

• Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.
• Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• May be responsible as Lead Biostatician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS/R annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met.
• May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions.
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.

Qualification Requirements

• Graduate degree in biostatistics or related discipline.
• Extensive experience in clinical trials demonstrated by the ability to lead multiple projects and programs of studies.
• Proficiency in programming (SAS/R).
• Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques.
• Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
• Experience with regulatory submissions preferred.
• Excellent written and verbal communication skills in English.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.