Senior Vice President, Biometrics

Department: Clinical

Employment Type: Full Time

Location: Remote

Description

Role Overview

• Strategy and leadership. Define and execute the biometrics vision, operating model, and multi-year roadmap aligned to the clinical development plan. Serve on the clinical development leadership team and represent Biometrics to executive management and the Board as needed.
• Biostatistics. Provide statistical leadership for trial design, sample size, endpoint selection, adaptive and Bayesian methods, interim analyses, and statistical analysis plans across all programs. Lead use of natural history data, external controls, and real-world evidence in support of development and regulatory strategy
• Regulatory interaction. Lead biometrics content and strategy for FDA, EMA, and other health authority interactions, including pre-IND, End-of-Phase meetings, Scientific Advice, INDs, and BLAs/MAAs. Ensure submission-ready datasets, ADaM/SDTM packages, and define files meet CDISC and agency standards.
• Statistical programming and data standards. Oversee SDTM and ADaM development, TLFs, integrated summaries, and programming validation. Establish standards, metadata repositories, and reusable macros that support quality and speed.
• Long-term follow-up and safety data. Partner with Clinical Safety and Clinical Operations on data strategy for long-term follow-up required for gene therapy programs, including DSMB and independent data monitoring committee support.
• Vendor and CRO oversight. Select, govern, and manage CROs and technology vendors for biometrics services, with clear performance metrics, quality agreements, and budget accountability.
• Clinical data management. Ensure high-quality, inspection-ready data collection, cleaning, and database lock across internal and CRO-managed studies. Oversee EDC selection and build, data review, external data integration, and risk-based quality management.
• Quality and compliance. Ensure compliance with GCP, ICH, 21 CFR Part 11, and applicable data privacy requirements. Maintain inspection readiness and lead biometrics participation in audits and inspections.
• People and organization. Lead, develop, and retain a high-performing team. Build a scalable organization through the transition from a development-stage company to a commercial-ready one, and manage functional budgets and resource planning.

Experience & Skills and Work Environment

• PhD in Biostatistics, Statistics, or a related quantitative field required; MS with exceptional experience may be considered.
• 15 or more years of biometrics experience in the biotechnology or pharmaceutical industry, including 7 or more years leading biometrics organizations 
• Proven track record leading biometrics for successful regulatory submissions (NDA/BLA/MAA) and approvals; experience with cell and gene therapy, rare disease, or ophthalmology/cardiology/neurology programs is strongly preferred.
• Deep knowledge of CDISC standards, ICH guidelines, FDA and EMA expectations, and statistical methodology for novel and adaptive designs.  Demonstrated experience with health authority interactions, DSMB support, and inspection readiness.  
• Technical proficiency with SAS, R, and statistical programming (SDTM, ADaM, TLFs), plus oversight of clinical data management and EDC.
• Experience managing CRO and vendor relationships and building scalable systems and processes.
• Strong executive presence, with the ability to communicate complex statistical concepts clearly to cross-functional leaders, regulators, and investors.
• Strategic thinking that connects data and statistical strategy to program value.
• Scientific rigor combined with pragmatism and speed.
• Cross-functional collaboration and the ability to influence without authority.
• Talent development and the ability to lead, build, and scale teams.
• Accountability for quality, timelines, and budget.

• Primarily desk-based, generally in an office or home office setting.
• May involve extended periods of sitting and computer use.
• Occasional travel may be required.

Life at Kriya

• Time Off & Work-Life Balance: Flexible Time Off ∙ Paid Parental & Medical Leave ∙ Paid Company Holidays
• Health & Wellness:  Fertility & Family Building Benefits ∙ Medical, Dental, and Vision Insurance ∙ Employee Assistance Program (EAP) ∙ Life Insurance ∙ Short- and Long-Term Disability Coverage
• Financial Security: Equity ∙ 401(k) with Company Match ∙ Identity Theft Protection
• And More!