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Kardigan · 3 days ago

Vice President, Biometrics

Princeton, NJ

Full-time

Onsite

Director/Executive

$342K/yr - $374K/yr

12+ years exp

Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The Vice President, Head of Biometrics will lead the strategic and operational direction of biostatistics, statistical programming, analytics, and clinical data management functions across the clinical development portfolio, contributing to clinical development and regulatory strategies.

Artificial Intelligence (AI)BiopharmaHealth CareMedical

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 organization’s 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

Drive the selection and optimization of data systems and scalable governance & SOP for data flow, data integrity, and oversight of CRO/vendor deliverables

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

Qualification

PhD in statisticsBiotech/pharmaceutical experienceRegulatory agency experienceCDISC requirements proficiencyStatistical software expertiseEDC systems understandingData management processesCollaboration skillsCommunication skillsProject management skillsDetail oriented

Required

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

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-performing, multidisciplinary teams