Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com
Brief Description:
The Principal Biostatistician will be responsible for performing, and validating statistical analyses in support of the clinical trial portfolio, in accordance with departmental SOP and guidelines, as needed and sit within the Data Sciences department.
Essential Functions:
- 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.
Minimum Requirements
- Master’s 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
- 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.
