Principal Biostatistician - Remote

Penfield Search Partners Ltd - Fairfield, CT

Full-time - Senior

Remote - Fairfield, CT

Professional, Scientific, and Technical Services

About the position

The Principal Biostatistician will be responsible for performing and validating statistical analyses to support the clinical trial portfolio within the Data Sciences department. This role involves collaboration with study teams, development of study protocols, and ensuring compliance with departmental SOPs and regulatory guidelines.

Responsibilities

• Support the development and implementation of study protocols.
• Review and provide input to data capture systems and participate in their validation.
• Support clinical development biostatistics with exploratory analyses necessary for submissions and regulatory queries.
• Work collaboratively with members of study teams to meet study and recurring report timelines.
• Review and contribute to protocol, eCRF design, dataset specifications plans at study level in accordance with best practices.
• Write statistical analysis plans and review those written by other statisticians.
• Perform and oversee data analysis and validation, and interpret analyses.
• Develop statistical programs to simulate clinical trial design operating characteristics and perform analysis.
• Prepare data displays and verify data accuracy and validity of analyses performed by statistical programming.
• Create and document archives of programs, outputs, and analysis files.
• Collaborate as the statistical subject matter expert with medical writers in the production of clinical reports, integrated summaries, and other documents.
• Learn drug development regulatory requirements as they relate to statistics.

Requirements

• Master's degree with more than 2 years of experience; OR PhD in statistics, mathematics or a related discipline with a statistical focus.
• Proficient in drug development regulations pertinent to statistical analysis.
• Proficient in SAS and R programming skills.
• Understanding of CDISC SDTM and ADaM models and standards is preferred.
• Excellent writing and communication skills.
• Demonstrated leadership abilities and excellent interpersonal skills.
• Able to work in a fast-paced, flexible, team-oriented environment.

Nice-to-haves

• Understanding of Oncology/Neuroscience therapeutic space.