Executive Director – Biostatistics

Executive Director – Biostatistics

Requirements

• Advanced degree in biostatistics, statistics, mathematics, or a related field.
• A minimum of 12 years of experience in biostatistics for clinical development, including extensive experience with Phase 3 clinical trials and New Drug Application (NDA) and/or Biological License Application (BLA) submissions.
• Strong expertise in statistical methods for diagnostic and clinical development, including mixed effects regression and time-to-event models, along with proficiency in SAS, R, and clinical data management systems.
• Proven experience leading biostatistics and data sciences in the biotechnology industry, aligning data strategies with program goals and driving innovation.
• Expertise in shaping and executing statistical strategies for clinical trials, ensuring data integrity, regulatory compliance, and scientific rigor.
• Experience preparing regulatory submission documents (statistical analysis plans, clinical study reports) and ensuring compliance with industry standards.
• Expertise in designing clinical trials and refining data collection processes with optimal statistical methodologies.
• Fluent in CDISC data standards, including SDTM and ADaM.
• Knowledge of FDA, EMA, and ICH regulations and guidelines related to clinical trials, biostatistics and data handling.
• Experience in outsourced vendor management and external partnership governance.
• Experience developing departmental standards and process improvement initiatives.
• Proven ability to lead and develop high-performing teams, align talent strategies with the company’s vision, foster innovation, and inspire teams while developing future leaders.
• Demonstrated ability to develop and implement growth-oriented strategies and initiatives.
• Advanced strategic thinking skills with a track record of anticipating and responding to industry trends.
• Excellent interpersonal and communication skills, with the ability to navigate complex organizational dynamics.
• Experience in talent development and aligning employee career goals with organizational objectives.

Responsibilities

• Develop and implement biostatistical strategies for clinical trials and research studies, ensuring they align with regulatory requirements and organizational objectives.
• Provide statistical leadership for the design and analysis of clinical trials, focusing on cardiovascular editing gene therapies.
• Serve as the biostatistics expert for clinical trial programs, from preclinical through late-stage development and regulatory submission.
• Oversee the design, analysis, and interpretation of clinical trial data, ensuring the use of advanced statistical methodologies, including survival analysis, Bayesian methods, and longitudinal data analysis.
• Conduct power and sample size calculations, ensuring the statistical rigor of study designs.
• Review and validate clinical trial data for consistency and clarity, ensuring accuracy throughout the trial lifecycle.
• Provide clear, actionable insights through statistical reports, presentations, and graphical data representations for clinical teams, senior leadership, and regulatory agencies.
• Assist in developing study protocols by incorporating statistical methodologies that support clinical objectives, participate in preparing and submitting regulatory filings to ensure statistical sections meet regulatory standards (e.g., FDA, EMA).
• Provide statistical consulting to researchers and clinical staff to optimize trial design and analysis in alignment with business and regulatory goals.
• Stay abreast of advancements in clinical research methodologies and biostatistics, adapting strategies to meet evolving industry trends and regulatory requirements.
• Ensure the highest standards of data accuracy, integrity, and consistency in all clinical trial data analysis.
• Oversee the review and audit of clinical trial data, ensuring compliance with industry best practices and regulatory requirements.
• Work closely with cross-functional teams, from clinical research, clinical operations, data management, and regulatory affairs to design and execute innovative clinical studies that drive progress and provide valuable insights.
• Forge strong partnerships with external collaborators, including CROs, academic institutions, and industry leaders, to accelerate program development and amplify the company’s impact.
• Develop lasting relationships with both internal and external stakeholders, fostering alignment and creating a collaborative environment that supports mutual success and growth.
• Make key decisions that influence the organization’s long-term performance and strategic objectives.
• Lead the growth and development of a high-performing biostatistics team by aligning talent strategies with the company’s vision, fostering a culture of collaboration, creativity, and excellence.
• Inspire and empower team members to thrive in a dynamic, fast-paced environment, while mentoring them to take on leadership roles and drive high performance, accountability, and innovation.
• Champion innovation by empowering teams to think creatively, embrace diverse perspectives, and implement best practices.
• Demonstrate strong interpersonal skills, effectively managing conflicts, fostering respectful interactions, and promoting a collaborative, inclusive workplace culture.

Preferred Qualifications

• Candidates who do not check off every box in the requirements are encouraged to apply.