Objective
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 – In collaboration with cross-functional team members, provide statistical leadership in the development and evaluation of study designs and methodologies to address clinical hypotheses. Responsibilities may include participation in early research design for new programs as well as the refinement and support of statistical approaches for studies already in progress, including late-stage clinical trials.
- Data Management – Partner with clinical operations, data management, and statistical programming teams to design, develop, and maintain fit-for-purpose clinical databases. Oversee and ensure robust data integrity controls, including reviewing edit checks and validation logic, defining analyzable and high-quality data requirements, and ongoing data quality monitoring. Establish and maintain efficient data archival systems suitable for multi-center and collaborative studies, and ensure thorough documentation of all data programming, validation, and archival processes.
- Data Analysis – Serve as a statistical advisor to clinical development leadership to determine appropriate analytical methodologies. Lead and/or oversee statistical programming and analysis activities across multiple research studies, utilizing a range of statistical models. Direct the creation of analysis datasets, data summaries, and statistical reports, primarily using SAS. Develop statistical analysis plans (SAPs) based on study protocols and define tables, listings, and figures (TLF) shells in accordance with the SAP. Author and review statistical sections of clinical documents, including study synopses, protocols, and clinical study reports. Evaluate the appropriateness of final statistical models and outputs, perform quality control and validation of work produced by statisticians and statistical programmers, and document methods and results through formal memoranda and reports. Provide ongoing statistical guidance for active and planned clinical studies. Manage biostatistics programming vendor to ensure 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, including datasets and programming documentation. Contribute to the development, maintenance, and continuous improvement of internal guidelines and Standard Operating Procedures (SOPs). Conduct statistical simulations to evaluate innovative or novel clinical trial designs. Prepare and present project updates for routine status meetings and maintain current knowledge of statistical methodologies, regulatory expectations, and industry best practices.
- Statistical Reporting – Contribute to the preparation and review of clinical trial deliverables, including clinical study reports, internal reports, regulatory-supporting documentation, academic publications, and scientific presentations for national and international meetings.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education / Experience
- 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, with significant experience supporting clinical drug development; oncology experience strongly preferred.
- Demonstrated expertise in advanced data manipulation and statistical analysis methodologies applied to clinical research.
- Deep expertise in applied statistics, including the design and analysis of complex datasets, such as imaging or other data-intensive clinical endpoints.
- Proficiency in multiple statistical software platforms, including at least two of the following: SAS, R, SPSS, or STATA.
- Strong skills in descriptive analysis and inferential analysis, statistical modeling, study design, and data visualization/graphical outputs.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Knowledge / Skill / Ability
- Demonstrated attention to detail, with the ability to interpret and apply regulatory requirements and industry standards in support of high-quality, compliant clinical and statistical practices.
- Exceptional written and verbal communication skills, with the ability to clearly convey complex technical concepts to both technical and non-technical audiences.
- Proven ability to work independently, manage complex projects, and drive change across cross-functional and matrixed organizations.
- Strong judgment and prioritization skills, with the ability to focus on critical issues while balancing competing short-term demands and long-term strategic objectives.
- Ability to manage multiple concurrent projects and deliver results on schedule maintaining rigorous quality standards.
- Demonstrated capacity to quickly develop fluency in relevant medical, scientific, and imaging-related concepts and terminology.
- Ability to effectively facilitate meetings and lead discussions in both in-person and virtual settings.
- Ability to travel up to 10%, as required.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 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.
Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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