Principal Biostatistician Neuroscience - Remote
Penfield Search Partners
- Fairfield, CT
- Contract
- Full-time
- 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.
- Support the development and implementation of study protocols.
- Review and contribute to protocol, eCRF design, dataset specifications plans at study level in accordance with best practices.
- Write statistical analysis plans, review statistical analysis plans written by other statisticians, perform and oversee data analysis and validation, and interpret analyses.
- Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, 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, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards.
- Masters degree with >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 and in the and
- Oncology/Neuroscience therapeutic space
- Proficient SAS & R programming skills
- An understanding of CDISC SDTM and ADAM models and standards is preferred.
- Excellent writing skills, communication skills, demonstrated leadership abilities, and excellent interpersonal skills.
- Able to work in a fast-paced, flexible, team-oriented environment.