Principal Biostatistician (Consultant)

The Principal Biostatistician position is responsible for designing and executing statistical analyses, providing statistical expertise to cross functional teams, and ensuring the quality and accuracy of statistical deliverables.

Essential Functions:

• Lead statistical activities for clinical trials and data analyses, including study design, statistical analysis plan development, and statistical analysis.
• Provide statistical expertise to cross functional teams, including clinical operations, data management, and regulatory affairs.
• Ensure the quality and accuracy of statistical deliverables, including statistical reports, tables, listings, and graphs.
• Participate in the development and review of clinical study protocols and case report forms (CRFs) to ensure appropriate statistical analysis.
• Develop and maintain SAS programs for statistical analysis in accordance with standard operating procedures (SOPs), good programming practices, and regulatory guidelines.
• Keep up to date with regulatory guidelines and industry standards related to biostatistics and ensure compliance with these guidelines.
• Participate in the development and maintenance of internal processes and standard operating procedures to improve statistical efficiency and consistency.
• Provide guidance and mentorship to junior statisticians.
• Interact with regulatory authority personnel.
• Other duties as assigned. Necessary Skills and Abilities:
• In-depth knowledge of statistical methodologies.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners.
• Strong project management skills, with the ability to manage multiple projects simultaneously.
• Knowledge of regulatory requirements and guidelines related to statistical analysis and reporting of clinical trial data.
• Ability to program in SAS and or R. Educational Requirements:
• Ph.D. in Biostatistics, or M.S. in Biostatistics. Experience Requirements:
• 6+ years of relevant work experience.
• Outsourcing industry experience required.
• Experience in clinical trial design, sample size calculations, and statistical analysis.
• Experience with CDISC data structures, such as SDTM and ADaM