Product SME – Clinical Data & Biometrics

Product SME – Clinical Data & Biometrics

Location: Alameda, CA-onsite

Position Summar

yWe are seeking an experienced Product Owner with deep expertise in Clinical Trials, Biometrics, and Clinical Data Management to lead the development of clinical data products and platforms. The ideal candidate understands how clinical trial data moves across the ecosystem—from protocol design and patient enrollment through EDC, data management, SDTM conversion, biometrics, statistical analysis, and regulatory submissions

.This role will serve as the bridge between Clinical Operations, Data Management, Biostatistics, Statistical Programming, and Data Engineering teams to define, prioritize, and deliver data products that support clinical development and AI-driven analytics

.Key Responsibilitie

• sOwn and manage the product roadmap for clinical data and biometrics platforms
• .Partner with Clinical Data Management, Biostatistics, Statistical Programming, Medical Affairs, and Data Engineering teams to define product vision and priorities
• .Develop and maintain product backlogs, user stories, acceptance criteria, and release plans
• .Drive requirements gathering and translate business needs into scalable data products and platform capabilities
• .Provide subject matter expertise on clinical trial data flow, including
• :Protocol → EDC → Data Management → SDTM → ADaM → Statistical Analysis → Regulatory Submissio
• nEnsure alignment with industry standards including CDISC, SDTM, ADaM, Controlled Terminology, and clinical data governance practices
• .Collaborate with engineering teams to design and deliver clinical data pipelines, integrations, and AI-ready datasets
• .Lead stakeholder discussions and prioritize enhancements based on business value and regulatory requirements
• .Support UAT, validation, release planning, and adoption of clinical data products
• .Drive initiatives related to data quality, metadata management, clinical standards, and data reuse across studies
• .Work closely with enterprise data and AI teams to enable advanced analytics, reporting, and machine learning use cases

.Required Qualification

• s8 years of experience in Clinical Trials, Biometrics, Clinical Data Management, or Clinical Data Platforms
• .Strong understanding of end-to-end clinical trial data lifecycle and data movement across clinical systems
• .Hands-on experience with EDC platforms such as Medidata Rave, Oracle InForm, Veeva EDC, or similar
• .Deep knowledge of CDISC standards including SDTM and familiarity with ADaM datasets
• .Experience working with Clinical Data Management, Biostatistics, Statistical Programming, and Data Engineering teams
• .Proven Product Owner or Product Management experience in healthcare, life sciences, or clinical research environments
• .Strong expertise in Agile methodologies, backlog management, user stories, and product prioritization
• .Experience supporting data integration, clinical data warehouses, and analytics platforms
• .Excellent communication and stakeholder management skills

.Preferred Qualification

• sExperience with clinical data lakes, modern cloud data platforms, or AI/ML initiatives
• .Familiarity with clinical systems such as CTMS, eTMF, RTSM/IRT, Safety, and Regulatory platforms
• .Experience supporting regulatory submissions and inspection-ready clinical data environments
• .Knowledge of GCP, FDA, EMA, and ICH guidelines related to clinical data