Senior Director of Biostatistics and Data Management

About the Company - The Senior Director of Biostatistics and Data Management position will lead and shape the data strategy at Ankyra Therapeutics and will be reporting to the Chief Medical Officer. As a key member of the clinical team, the Senior Director will be responsible for overseeing all aspects of biostatistics and data management for our preclinical and clinical development. This role will play a critical part in driving data-driven decision-making and ensuring the statistical integrity of our clinical trials from early-stage through late-stage development. The ideal candidate will provide high level strategic input to the clinical trial design, oversee basic statistical methods and analyses, development of databases and ensure high quality and timely deliverables related to biostatistics. The Senior Director will play an integral role in both preclinical and clinical-related components of regulatory submissions, including Clinical Trial Applications and New Drug Applications. This position may represent Biostatistics and Data Management on cross-functional teams across the company’s portfolio, providing subject matter expertise to the executive leadership. An essential component to the position is the ability to direct multiple drug programs and contribute to advancing early clinical development. The candidate will bring a strategic mindset, deep technical expertise, and hands-on leadership experience, in a fast-paced, team-oriented biotechnology environment where flexibility and cross-functional collaboration are essential.

Responsibilities -

• Develop and implement a comprehensive biostatistics and data management strategy that supports the company’s preclinical and clinical development objectives and aligns with regulatory requirements.
• Serve as the primary statistical and data management expert, providing insights and guidance on clinical trial design, data interpretation, and regulatory submissions.
• Contribute to the overall clinical development strategy, ensuring that data management and statistical considerations are integrated into decision-making processes.
• Oversee all data management activities, including the development and execution of data management plans, CRF design, database setup, data validation, and database lock.
• Ensure data integrity, quality, and compliance with regulatory standards (e.g., CDISC, GCP) across all clinical trials.
• Develop key results memos (KRM) and clinical study reports (CSR).
• Support development of key safety and regulatory documents, including Development Safety Update Report (DSUR) and Investigator’s Brochure (IB).
• Provide statistical support in the design and analysis of pre-clinical experiments, biomarker studies and immunogenomic data.
• Assist with safety data management and analysis.
• Lead the management of external vendors (CROs, EDC providers) to support data management and statistical functions.
• Establish data transfer agreements with external vendors
• Provide data analysis and statistical support for exploratory biomarker data
• Lead the design and implementation of statistical analysis plans, ensuring that clinical trial designs are statistically sound and aligned with study objectives.
• Provide statistical expertise in the development of study protocols, including sample size determination, randomization schemes, and endpoint analysis.
• Oversee the analysis and interpretation of clinical trial data, ensuring accuracy and robustness in statistical reporting.
• Present and defend statistical methodologies and results to regulatory agencies, scientific advisory boards, and key stakeholders.
• Lead the statistical components of regulatory submissions, including the preparation of statistical sections for NDAs, BLAs, and MAAs.
• Ensure that all data management and biostatistics activities are conducted in compliance with relevant regulatory guidelines (FDA, EMA, ICH) and company policies.
• Build, lead, and mentor a high-performing team of biostatistics and data management professionals, fostering a culture of collaboration, innovation, and continuous improvement.
• Participate in strategic discussions with senior leadership, contribute to overall company direction and long-term planning and provide strategic and operational leadership to the team, ensuring alignment with company goals and efficient execution of responsibilities.
• Cultivate a strong network of external partners, consultants, and key opinion leaders to support the company's clinical programs.
• Work closely with Clinical Development, Clinical Operations, Regulatory Affairs, Research & Development, and other departments to ensure seamless integration, communication and collaboration of biostatistics and data management into clinical programs.

Qualifications -

• Ph.D. in Biostatistics, Statistics, Data Science, or a related field is preferred. Candidates with a master’s degree will be considered with a minimum of 10 years of experience in data management and biostatistics within the biotechnology, pharmaceutical, or CRO industries, with at least 5 years in leadership role.
• Experience in a small biotech or startup environment is highly desirable.
• Proficiency in statistical software (e.g., SAS, R) and electronic data capture (EDC) systems. Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory submission processes.
• Extensive experience with regulatory submissions and interactions with regulatory agencies such as the FDA and EMA. In-depth understanding of GCP and ICH guidelines.
• Immuno-Oncology experience is preferred but not required.
• Demonstrated ability to lead and inspire cross-functional teams, with strong strategic thinking, decision-making, and problem-solving capabilities.
• Ability to develop high-quality publications and presentations to effectively communicate statistical analyses and data findings.
• Excellent verbal and written communication skills, with the ability to present complex data and statistical concepts to diverse audiences, including non-technical stakeholders and regulatory bodies.
• Proven track record of thriving in a fast-paced, dynamic environment, with the ability to balance strategic vision with hands-on execution.
• Experience building and managing a team of Biostatisticians and Data Management professionals is preferable.