Principal Biostatistician

About the role

Our client which is a leader in research and development of scientifically-defined and medically-proven solutions for the skin, hair and nails in Fort Worth, TX is in need of a Principal Biostatistician.

Duties and Responsibilities

• Serve as biostatistics leader for a particular therapeutic indication of a project.
• Participate and interact with clinical and cross-functional teams in the development of protocols, study design and endpoints discussions.
• Develop/Review Statistical Analysis Plan (SAP) and provide sample size calculations.
• Responsible for the Biostatistics project management including but not limited to overseeing execution of statistical analyses as per SAP, vendor management, directing statistical programming, mentoring junior statisticians, update status of project to management on a regular basis, and escalate issues in a timely manner.
• Ensure high quality and timely delivery of tables/figures/listings and statistical reports.
• Prepare or review statistical sections of clinical study report and overall summaries.
• Execute quality assurance procedures on work produced by others, ensuring statistical analysis is being done according to specifications.
• Interact with Regulatory Agencies on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations.
• Provide support for publication.
• Author or review statistical SOPs, Guidelines and Working Instructions
• Keep up-to-date with the latest statistical methodologies development related to clinical trials.
• Give statistical presentations to internal/external groups.
• May function as study level statistician, if needed.
• May serve as first point of contact for the biostatistics department within the same therapeutic indication.
• Perform other duties/tasks as required or assigned.

Qualifications & Requirements

• Minimum of 8-10 years of industry experience in leading statistical activities as a Biostatistician in supporting clinical trials.
• Minimum of 6 years of SAS programming experience and knowledge of CDISC requirements.
• Extensive knowledge of statistical methodologies and study designs.
• Minimum 3 years of experience with regulatory support and interaction, preferred
• Experience in providing vendor oversight.
• Proven ability to manage multiple projects across therapeutic indications.
• Proficiency in statistical programming in SAS. Knowledge of R and other programming languages is preferred.
• Excellent verbal and written communication skills.
• Ability to work as a team and have skills to convince your position in cross-functional teams.
• Proven ability to present and communicate statistical concepts and ideas clearly.
• Must be able to work with minimum supervision.

Additional Information

All your information will be kept confidential according to EEO guidelines.