Senior Vice President, Biometrics
Kriya Therapeutics, Inc.
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Job summary
Kriya Therapeutics, Inc. seeks a Senior Vice President, Biometrics to lead biostatistics, programming, and data management across the clinical pipeline.
You will set the data strategy, ensure regulatory submission quality, and build a team and systems to move programs from early studies to registration. You will apply expertise in trial design, external controls, and modern statistical methods to deliver rigorous, efficient data packages for rare and common diseases.
Qualifications
- PhD in Biostatistics or related quantitative field; MS with exceptional experience may be considered.
- 15+ years biometrics experience in biotech/pharma, including 7+ years leading biometrics
- Proven track record leading biometrics for regulatory submissions (NDA/BLA/MAA) and approvals
- Deep knowledge of CDISC, ICH, FDA/EMA expectations; health authority interactions
- Expertise with SAS, R, SDTM/ADaM, and programming standards
- Experience managing CROs/vendors and scalable systems/processes
- Strong executive presence and cross-functional communication
- Strategic thinking connecting data strategy to program value
- Talent development and building scalable teams
- Accountability for quality, timelines, and budget
Responsibilities
- Define biometrics vision, operating model, and multi-year roadmap; represent Biometrics to leadership and Board
- Provide statistical leadership for trial design, sample size, endpoints, adaptive methods, interim analyses
- Lead regulatory strategy for FDA/EMA; ensure submission-ready datasets and CDISC standards
- Oversee SDTM/ADaM development, TLFs, and metadata standards; reusable macros
- Partner on long-term follow-up and safety data for gene therapy programs
- Select, govern, and manage CROs/vendors with budget accountability
- Ensure high-quality, inspection-ready data; oversee EDC selection and data management
- Maintain GCP/ICH compliance and inspection readiness; support audits/inspections
- Lead, develop, and retain a high-performing biometrics organization; scale with company
- Collaborate cross-functionally to align data strategy with program value
Skills
Education
Tools
Job description
Department: Clinical
Employment Type: Full Time
Location: Remote
Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.
We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.
We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”
The Senior Vice President, Biometrics leads all biometrics functions at Kriya Therapeutics, including biostatistics, statistical programming, and clinical data management. This leader sets the statistical and data strategy across the clinical pipeline, ensures the integrity and quality of data supporting regulatory submissions, and builds the team and systems needed to move programs from early clinical studies through registration. The role is a key member of the clinical development leadership team and a trusted partner to Clinical, Regulatory, Translational, CMC, and Quality.
The SVP will apply deep expertise in rare and common disease trial design, novel endpoints, and natural history and external control approaches to a modality where the data package must be both rigorous and efficient.
Key Responsibilities
- 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
- 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.
Work Environment
- 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.
We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.
We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.
Rewards & Benefits
- 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!
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