VP, Biometrics

Company Overview

Taysha Gene Therapies is a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations.

Position Title: Vice President, Biometrics

Reports to: Chief Medical Officer

Overview of Position

The Vice President, Biometrics is responsible for providing strategic planning, oversight and delivery of the biostatistics, data management, and programming functions throughout the lifecycle of the clinical development program including the study design, data collection and analysis, and interpretation of results. The Biometrics team provides a range of services for quantitative research including study design, data management, data analysis, study documentation, regulatory compliance, data reporting and data dissemination. This role will work collaboratively and strategically with our cross-functional teams and external partners to ensure that all data deliverables generated by Taysha Gene Therapies are accurate, timely, consistent, and executed with the highest Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP) and quality standards, in accordance with established contractual agreements, budgets and study timelines.

Essential Duties

• Build, lead, and manage the biostatistics, data management and programming teams at Taysha.
• Work with cross-functional teams to ensure biostatistics, data management, and programming services meet the organization’s research staff’s needs.
• Hire and manage a strong biometrics team comprised of employee and contract resources.
• Review scientific proposals, study protocols, papers, and final study reports to ensure appropriate use of statistical and data management procedures and interpretation.
• Influence proper use of statistics and adherence to data management standards across a comprehensive research portfolio.
• Oversee biometric work in designing and implementing analysis plans for research studies to ensure that sound analytical procedures are applied.
• Provide strategic clinical data management workflow for global development programs ensuring all necessary data quality control measures are in place and followed.
• Utilize data management tools to streamline operations.
• Collaborate with cross-functional partners to identify clinical data key performance indicators (KPIs) and key quality indicators (KQIs) to ensure aligned deliverables.
• Establish company-wide standards for electronic case report forms, case report form completion guidelines, data transfer/handling agreements, statistical programming, etc.; lead efforts to drive adoption of external innovations related to clinical data to accelerate drug development, optimize risk-based quality management, and enhance analytic capabilities.
• Prepare and review clinical data-related documentation, including clinical protocols, data management plans, CRFs, etc.
• Participate in developing the clinical components of regulatory submissions and transfer of clinical data as needed, ensuring data deliverables meet regulatory submission requirements.
• Ensure performance of external vendors responsible for clinical data deliverables (e.g., cycle times for clinical database setup, UAT, edit checks, query quality, database migration, clinical data transfers, database cleaning, database locking and archival, etc.); ensure quality completion of all clinical data related deliverables.
• Responsible for clinical data collection, handling, transfer and storage via secure and authorized methods while ensuring compliance with GDPR and local privacy requirement standards.
• Responsible for clinical data transfer and handling aspects necessary to support program advisory committees, adjudication committees, data monitoring committees, and/or external audiences (e.g., health authorities, publication, scientific exchange, etc.).
• Lead portfolio-level clinical data related risk identification, management, and mitigation efforts.
• Conduct advanced-level statistical analyses or database development. This may include serving as lead biostatistician or lead data manager for select studies or trials.
• Accountable for clinical data performance of regulated clinical trials, including inspection readiness.
• Responsible for regular quality checks, including results reporting to senior leadership.
• Contribute to development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems and tools.

Skill & Education Requirements

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills with the ability to develop relationships with key stakeholders.

• B.S./B.A. degree required; advanced degree highly desirable.
• 12+ years’ clinical research or equivalent life sciences experience with progressive management experience in data management and biostatistics.
• Experience with all aspects of data collection and handling (startup through archive), required.
• High-level expertise in various statistical areas of work applicable to research portfolios.
• Understanding of drug development and program management from pre-IND through regulatory filing is essential.
• Thorough understanding of CDISC and SDTM standards.
• Experience with Risk Based Monitoring, including implementation and management of data analytics tool(s).
• Advanced skills in multiple statistical areas or database development.
• Demonstrated excellence in complex project management while managing multiple projects/priorities effectively.
• Experience in regulatory filings (e.g., NDA, BLA, MAA)
• Experience with GCP regulatory inspections desired.
• Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
• Excellent written and verbal communication skills.
• Ability to function independently as lead statistician or lead database manager.
• Current on scientific and ethical principles and industry best practices in biomedical and other non-clinical research analysis
• Experience in rare/orphan diseases is highly desirable.
• Experience with CDISC standards for eCTD submissions is strongly preferred.
• Ability and willingness to travel up to 10% of the time, as needed (domestic and international).

Base compensation range at time of posting: $300,000 – 400,000

The actual base salary depends, in part, on the successful candidate’s qualifications for the role, including education and experience. Taysha offers a comprehensive compensation and benefits program to eligibleemployees, including Individual Stock Option awards; ESPP program; eligibility to participate in performancebonus program; company-sponsored 401(k) with matching contribution; eligibility for medical, dental, visionand prescription drug benefits and a generous vacation/holiday schedule.

Note this job description is not designed to cover or contain a comprehensive listing of activities, duties orresponsibilities that are required of the employee for this job. Duties, responsibilities, and activities maychange at any time with or without notice.

Taysha is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Allemployment decisions at Taysha are based on business needs, job requirements and individual qualifications,without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.