Senior Manager of Biostatistics

Job Overview

As Senior Manager of Biostatistics, you will serve as the trial statistician for assigned clinical studies. You will contribute to protocol development, statistical analysis plans, database design, statistical programming activities, clinical study reports, regulatory responses, and scientific presentations.

You will independently apply statistical methods to clinical trial data while receiving guidance on especially new or complex matters. The position also includes vendor oversight, issue resolution, timeline management, and participation in the development of innovative statistical approaches.

Key Responsibilities

• Serve as the lead trial statistician for assigned clinical studies.
• Work with cross-functional teams on study planning, execution, analysis, and reporting.
• Develop statistical sections of clinical trial protocols and statistical analysis plans.
• Select appropriate statistical methods based on study objectives and trial design.
• Participate in database design meetings to ensure collected data meet quality and analysis requirements.
• Collaborate with statistical programmers on tables, listings, graphs, datasets, and validation activities.
• Analyze clinical trial data and interpret results according to study protocols.
• Apply both standard and complex statistical techniques to planned and ad hoc analyses.
• Prepare written reports and presentations that communicate study findings clearly.
• Provide statistical input for clinical study reports, scientific publications, and conference materials.
• Support responses to statistical questions and requests from regulatory authorities.
• Recommend strategies that improve or optimize clinical trial design.
• Identify potential statistical, technical, quality, or timeline risks and implement solutions.
• Coordinate with external vendors and review deliverables for quality, accuracy, and timeliness.
• Represent biostatistics within project and cross-functional study teams.
• Contribute to the development and application of innovative statistical methodologies.

Required Qualifications

• PhD or equivalent degree in Statistics, Biostatistics, or a related discipline with at least 36 months of relevant professional experience.
• Alternatively, a Master’s degree in Statistics, Biostatistics, or a related discipline with at least 60 months of relevant professional experience.
• Strong knowledge of clinical trial design principles and statistical methodology.
• In-depth understanding of the phases and processes involved in drug development.
• Experience planning, analyzing, interpreting, and reporting clinical trial results.
• Ability to develop protocols and detailed statistical analysis plans.
• Experience working with clinical data management and statistical programming teams.
• Ability to independently apply complex statistical techniques to clinical research data.
• Strong written and verbal communication skills.
• Ability to explain statistical findings to both technical and non-technical stakeholders.
• Experience working effectively within multidisciplinary and cross-functional teams.
• Strong analytical, problem-solving, organizational, and project management abilities.

Relevant Professional Experience

• Clinical trial protocol and statistical analysis plan development.
• Clinical study reporting and regulatory submission support.
• Collaboration with SAS programmers or other statistical programming professionals.
• Vendor management and quality review of statistical deliverables.
• Preparation of tables, listings, graphs, presentations, and scientific manuscripts.
• Identification and resolution of study design, analysis, quality, and timeline issues.
• Statistical support for regulatory agency questions and requests.

Work Arrangement

• Full-time employment.
• Remote position within the United States.
• Collaboration with clinical and operational teams across multiple functions.
• Participation in project meetings, study planning, and regulatory activities.

Compensation and Benefits

The annual base salary range for this position is $155,000 to $200,000. Actual compensation may vary based on relevant skills, education, experience, qualifications, and work location.

• Eligibility for the company’s annual bonus plan.
• Potential eligibility for discretionary equity awards.
• Employee Stock Purchase Plan participation.
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Flexible Spending Account and Health Savings Account options.
• Life insurance.
• Paid time off.
• Employee wellness benefits and resources.