Penfield Search Partners Ltd - Fairfield, CT
posted 16 days ago
Full-time - Senior
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 collaborating with study teams, developing study protocols, and ensuring compliance with departmental SOPs and regulatory guidelines. The position requires strong leadership and communication skills, as well as proficiency in statistical programming and analysis.
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.
- 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.
- 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 and integrated summaries.
- 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 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.
Nice-to-haves
- Experience in the Oncology/Neuroscience therapeutic space.
Benefits
- Salary commensurate with experience.
