Head of Biometrics

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.