We are a pioneering gene therapy company dedicated to revolutionizing treatments for monogenic diseases of the central nervous system. Our patient-centric approach drives our mission to develop and deliver innovative AAV-based gene therapies for both rare and large patient populations.
Position Title: Vice President, Biometrics
Reporting to: Chief Medical Officer
Overview
As the Vice President of Biometrics, you will play a pivotal role in shaping the strategic direction and execution of biostatistics, data management, and programming functions across our clinical development programs. Working closely with cross-functional teams and external partners, you will ensure the integrity, accuracy, and timeliness of all data deliverables in alignment with industry standards and regulatory requirements.
Key Responsibilities
Lead and nurture the biostatistics, data management, and programming teams.
Collaborate with cross-functional teams to meet research needs effectively.
Drive recruitment and management of a skilled biometrics team.
Review and guide the implementation of statistical and data management procedures.
Provide strategic oversight of clinical data management workflows.
Establish and uphold company-wide standards for data management practices.
Contribute to the development of regulatory submissions and clinical data transfer processes.
Oversee the performance of external vendors involved in clinical data deliverables.
Ensure compliance with data handling regulations and privacy standards.
Lead risk identification and mitigation efforts related to clinical data.
Conduct advanced statistical analyses and database development as needed.
Maintain readiness for regulatory inspections and quality assurance checks.
12 years of experience in clinical research or life sciences with progressive management roles.
Proficiency in data collection, handling, and statistical analysis.
Strong understanding of drug development processes and regulatory requirements.
Familiarity with CDISC and SDTM standards.
Experience with Risk-Based Monitoring and data analytics tools.
Excellent project management and problem-solving skills.
Knowledge of regulatory filings (e.g., NDA, BLA, MAA) and GCP inspections.
Ability to thrive in a dynamic, fast-paced environment.
Exceptional communication and interpersonal skills.
Additional Information
Salary Range: $300,000 - 400,000 (Base compensation at time of posting)
Comprehensive benefits package including stock options, 401(k), medical, dental, vision, and more.
Equal Opportunity Employer fostering diversity and inclusivity.
Please note that this job description may evolve over time to reflect changing responsibilities and priorities.
We welcome candidates who share our commitment to innovation and excellence to join our team in advancing gene therapy for the benefit of patients worldwide.
Employment Type: Full-Time
Seniority level
Executive
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Human Resources Services
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