Principal Biostatistician

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

Job Description: The Principal Biostatistician will be responsible for performing, and validating statistical analyses in support of Medical Affairs, inclusive of overseeing the work of programming for external vendors in accordance with departmental SOP and guidelines, as needed and sit within the Medical Affairs Statistics, Epidemiology and RWE branch of the Data Sciences department.

Essential Functions:

• Develop, design, and oversee or perform post-hoc analyses of existing databases and meta-analyses as needed and appropriate.
• 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.
• Develop and review SAP, TLF Shells, statistical reports, and other key study documents.
• Review and provide input to study-specific data capture systems and participate in their validation.
• Create and document archives of programs, outputs, and analysis files.

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, but not required
• Excellent writing and communication skills, demonstrated leadership abilities, and excellent interpersonal skills.
• Able to work in a fast-paced, flexible, team-oriented environment