[Hiring] Senior Director, Biostatistics @Perspective Therapeutics

Role Description

Reporting to the Chief Medical Officer, the Senior Director, Biostatistics, provides strategic and operational leadership for an established biostatistics function supporting the design, analysis, evaluation, and reporting of clinical trials. The role is accountable for overseeing end-to-end clinical data workflows, ensuring the high-quality evaluation of clinical data, and maintaining robust systems and processes to support efficient trial execution. The Senior Director will further develop and mentor biostatistics staff to ensure the continued effectiveness and scalability of this critical function.

Essential Functions

• Study Design:
  • Provide statistical leadership in the development and evaluation of study designs and methodologies to address clinical hypotheses.
  • Participate in early research design for new programs and refine statistical approaches for ongoing studies, including late-stage clinical trials.
• Data Management:
  • Partner with clinical operations, data management, and statistical programming teams to design, develop, and maintain clinical databases.
  • Ensure robust data integrity controls, including reviewing edit checks and validation logic.
  • Define analyzable and high-quality data requirements and ongoing data quality monitoring.
  • Establish and maintain efficient data archival systems for multi-center and collaborative studies.
  • Document all data programming, validation, and archival processes.
• Data Analysis:
  • Serve as a statistical advisor to clinical development leadership.
  • Lead and/or oversee statistical programming and analysis activities across multiple research studies.
  • Direct the creation of analysis datasets, data summaries, and statistical reports, primarily using SAS.
  • Develop statistical analysis plans (SAPs) based on study protocols.
  • Author and review statistical sections of clinical documents.
  • Evaluate the appropriateness of final statistical models and outputs.
  • Perform quality control and validation of work produced by statisticians and statistical programmers.
  • Provide ongoing statistical guidance for active and planned clinical studies.
  • Manage biostatistics programming vendor for timely, high-quality, and compliant statistical deliverables.
• General Support:
  • Provide expert statistical review, validation, and consultation for internal and external projects.
  • Communicate findings clearly to stakeholders and maintain complete study archives.
  • Contribute to the development and maintenance of internal guidelines and SOPs.
  • Conduct statistical simulations to evaluate innovative clinical trial designs.
  • Prepare and present project updates for routine status meetings.
  • Maintain current knowledge of statistical methodologies, regulatory expectations, and industry best practices.
• Statistical Reporting:
  • Contribute to the preparation and review of clinical trial deliverables.

Qualifications

• Master’s degree in Biostatistics, Statistics, or a related quantitative discipline required; PhD strongly preferred.
• Minimum of 10 years of progressive experience in the pharmaceutical, biotechnology, or academic research environment.
• Significant experience supporting clinical drug development; oncology experience strongly preferred.
• Demonstrated expertise in advanced data manipulation and statistical analysis methodologies.
• Deep expertise in applied statistics, including the design and analysis of complex datasets.
• Proficiency in multiple statistical software platforms, including at least two of the following: SAS, R, SPSS, or STATA.
• Strong skills in descriptive analysis, inferential analysis, statistical modeling, study design, and data visualization.

Requirements

• Demonstrated attention to detail with the ability to interpret and apply regulatory requirements.
• Exceptional written and verbal communication skills.
• Proven ability to work independently and manage complex projects.
• Strong judgment and prioritization skills.
• Ability to manage multiple concurrent projects and deliver results on schedule.
• Demonstrated capacity to quickly develop fluency in relevant medical, scientific, and imaging-related concepts.
• Ability to effectively facilitate meetings and lead discussions.
• Ability to travel up to 10%, as required.

Work Environment

• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Willingness to complete safety training within allotted timeframes and work in a team-based environment.