Senior Biostatistician Consultant

Clinchoice - Philadelphia, MS

Full-time - Senior

Philadelphia, MS

1,001-5,000 employees

Administrative and Support Services

About the position

The Senior Biostatistician Consultant at ClinChoice is a client-facing role that combines the stability of working for a global CRO with the opportunity to work directly with a single sponsor. This position involves significant responsibilities in protocol development, statistical oversight, and mentoring of peers, ensuring high-quality statistical analysis and reporting in clinical trials.

Responsibilities

• Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
• Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
• Ensure that data for statistical analyses are complete, accurate, and consistent.
• Manage statistical analysis plans and ensure the accuracy and timeliness of statistical input into reports or decisions.
• Validate analysis and explore alternative analysis strategies as needed.
• Demonstrate extensive understanding of statistical concepts and methodologies, correcting flaws in scientific reasoning and statistical interpretation.
• Ensure accuracy and consistency of statistical tables, figures, and data listings, and the accuracy of report text.
• Oversee the statistical methods section for reports, correcting common flaws in interpretation and ensuring adherence to report guidelines.
• Mentor peers regarding statistical methodology and provide training to less experienced statisticians.
• Manage activities of statisticians across projects, coordinating assignments and reviewing work to ensure timely and high-quality project delivery.

Requirements

• MS or PhD in Statistics, Biostatistics or related field; PhD with 3-5 years of experience or MS with 6-8 years of experience.
• Strong experience with Oncology therapeutic area.
• Strong oral and written communication skills, with the ability to effectively communicate internally and with clients.
• Demonstrated understanding of statistics, drug development processes, and relevant FDA regulations.
• Experience in the pharmaceutical, CRO, or related industry with clinical trials, including interaction with Regulatory Agencies, especially FDA.