Vice President, Head of Biometrics (Biostatistics, Statistical Programming and Data Management)

In this highly visible role, the Vice President, Head of Biometrics will be a core member of BlueRock’s Leadership Team and act as the leader for all of Biostatistics, Statistical Programming and Data Management. The Vice President will report directly to the Senior Vice President, Head of Clinical Development and will play a foundational role in the development strategy for all programs as well as all regulatory and health authority interactions. The Head of Biometrics will be responsible for developing and leading a high performing team of biostatisticians, programmers, and data managers to meet the needs of BlueRock’s growing pipeline.

Responsibilities:

• Leads and provides strategic input to ensure optimized clinical development planning in close collaboration with other senior functional leads
• Builds, leads and guides the broader Biometrics team including the biostatistics, statistical programming and data management teams in proportion with the company’s objectives and developing pipeline
• Lead and oversee the statistical content and contribute to the overall strategy in all regulatory submissions and interactions
• Manage and oversee the work of the biostatisticians, programmers and data managers in designing and analyzing clinical trials using innovative statistical methods/strategies consistent with the company’s objectives
• Mentor biostatisticians, programmers and data managers and promote research of innovative methods, teamwork and quality
• Participate in establishment of efficient processes, standards and SOPs
• Manages and oversees any required internal and vendor provided statistical, programming or data management support
• Consult with and support other functions including Research and Preclinical Development

Minimum Requirements:

• PhD in Statistics, Biostatistics or Applied Mathematics (or equivalent education/experience years)
• Ability to actively provide hands-on support as the biometrics function develops and matures
• Pharmaceutical/Biotechnology industry experience with a demonstrated track record
• In-depth knowledge and extensive experience in drug development statistical methodologies and strategies
• Extensive regulatory interactions experience is required
• Well-equipped to work cross-functionally in a collaborative matrixed environment with strong communication and interpersonal skills
• Excellent interpretation and presentation skills and ability to communicate statistical concepts and data to non-statisticians
• Managerial experience and proven ability to lead by example within a high-growth culture
• Innovative focus and ability to champion and advance novel concepts
• Experience in neurology, ophthalmology, and/or rare disease is a plus

Working Environment:

• Full time
• Remote or hybrid can be arranged  

#LI-AL1