Vice President, Biometrics

This position is 4-day onsite in Princeton, NJ

Job Overview 

The Vice President, Biometrics leads the strategic, scientific, and operational direction of all biostatistics, statistical programming, analytics and clinical data management functions across the clinical development portfolio at Kardigan.  Operating in a lean, faced-paced environment, the incumbent will lead biometrics support across all clinical programs and actively contribute to the clinical development and regulatory strategy and submissions.  This role is a member of the Development Operations & Biometrics leadership team, and, as such, contributes to portfolio strategy, evidence generation, and long-range planning. 

Essential Duties and Responsibilities 

• Provide expert biometrics and statistical guidance for study design, go/no-go decisions, and overall clinical portfolio optimization

• Serve as a key member and thought partner on clinical development plan, molecule strategy and disease area strategy, partnering closely with Medical, Clinical Operations, Safety, and Regulatory to ensure biometrics insights inform trial design, operational planning, and launch strategy

• Develop the biometrics function and strategy aligned with the organizations clinical development goals. Lead the recruitment, on-boarding, and management of direct reports and external vendors and consultants 

• Oversee integrated data strategies across trials and ensure delivery of the statistical analysis strategy for clinical development programs (including target product profiles), clinical development plans, endpoint strategy, statistical analysis plans (SAPs), reports and manuscripts, and statistical analysis required to support development 

• Ensure data interpretation and statistical analysis support high-integrity decision making and regulatory submissions

• Act as the primary biometrics representative for regulatory interactions and serve as a thought partner on regulatory submission activities. Ensure that all data and information submitted are in compliance with regulations (eg, ICH E6/E9, 21 CFR Part 11, GCP) and global data standards & regulatory requirements for the submission

• Champion modern analytics, automation, RWE integration, and data visualization tools to improve efficiency and data quality 
• Oversee end-to-end clinical data management lifecycle, including CRF design, data collection, edit checks, builds and locks
• Oversee standards for data acquisition, CDISC compliance, data cleaning, query resolution, and overall data quality ready for regulatory submission
• Drive the selection and optimization of data systems (eg, EDC, data repositories) and scalable governance & SOP for data flow, data integrity, and oversight of CRO/vendor deliverables
• Design a future state clinical data management function transforming into an automated and ‘real time’ data function and reducing site & patient burden
• Drive the organization’s data-driven culture, enabling rapid, high-quality decision making through analytics, modeling and innovative data solutions
• Establish best practices, SOPs, and governance frameworks for data flow and analysis across programs

Qualifications and Preferred Skills 

• PhD in a statistics discipline with at least 12+ years of experience in statistics related to the biotech/pharmaceutical industry, including 5+ years of leading teams.
• Prior experience working in small fast-paced company highly preferred. 

• Extensive experience in drug development and working with regulatory agencies such as FDA and EMA 

• Proficiency in CDISC requirements for regulatory submissions, including expertise with preparation and submission of data in STDM, ADaM, and SEND data standards
• Strong understanding of EDC systems, data standards, and end-to-end data management processes
• Must have a thorough understanding of statistical software (e.g., SAS, Sigma Plot/Stat) and the ability to demonstrate expert knowledge of statistical principles and concepts. 

• Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required 

• Excellent collaborator, communicator (verbal & written), and influencer across technical and non-technical audiences

• Detail and process oriented and demonstration of strong project management skills. 

Demonstrated success in leading high