Job Details

Company Overview:

A dynamic, clinical-stage biopharmaceutical organization focused on developing innovative small molecule therapies to address significant unmet medical needs in various therapeutic areas is seeking a seasoned leader. The company is advancing a robust pipeline of internally developed programs, with multiple candidates currently in clinical trials targeting serious health conditions.

Job Summary:

The Vice President, Biometrics Lead will spearhead the strategic vision and operational execution of the Biometrics function, encompassing Biostatistics, Data Management, Statistical Programming, and Clinical Systems. Reporting to a senior executive in clinical development, this role will shape policies, procedures, and drug development strategies while collaborating closely with internal teams and external partners. The position requires a blend of technical expertise, regulatory acumen, and scientific rigor to drive clinical programs forward.

Key Responsibilities:

• Develop and implement the strategic direction for the Biometrics team.
• Build and lead a high-performing department, overseeing organizational structure and staff development across Biostatistics, Data Management, Statistical Programming, and Clinical Systems.
• Direct all biostatistics activities for clinical development projects, ensuring innovative study designs, robust analysis plans, and adherence to regulatory standards.
• Provide expert statistical guidance on clinical trial design, data collection methods, analysis plans, study reports, and regulatory submissions.
• Leverage epidemiological methods to analyze real-world/observational data, supporting sample size calculations and strengthening development evidence.
• Ensure compliance with global regulatory requirements and standards, offering technical review of statistical methodologies, programming, databases, and clinical systems.
• Act as the primary biostatistics liaison for protocol reviews, strategic partnerships, safety evaluations, and scientific publications.
• Partner with senior leaders to maintain high development standards, challenge assumptions, and foster cross-functional collaboration.
• Oversee sponsor/CRO relationships, resolving issues and ensuring quality deliverables.
• Engage with regulatory authorities to align clinical studies with expectations and secure approvals.
• Drive the creation of best practices, standard operating procedures (SOPs), and operational standards for biostatistics.

Qualifications:

• Ph.D. in Statistics or a related discipline with 15+ years of experience in the pharmaceutical industry, or a Master's degree in Statistics with 20+ years of equivalent experience.
• Comprehensive understanding of international regulatory guidelines (e.g., ICH) and clinical development processes.
• Proven track record in recruiting, mentoring, and developing high-caliber teams.
• Advanced proficiency in statistical analysis software (preferably SAS), with familiarity in additional platforms a plus.
• Broad experience across Phases 1-4 of clinical development in diverse therapeutic areas preferred.
• Exceptional communication skills, with the ability to explain complex statistical concepts to non-technical stakeholders.
• Strong organizational, problem-solving, and leadership abilities, thriving in a collaborative team environment.
• In-depth knowledge of biostatistics best practices and procedures.
• Adaptable and capable of managing multiple priorities in a fast-paced, dynamic setting.