Sr. Director, Product Management Biostatistics SME

Sr. Director, Product Management Biostatistics SME

Location NJ/NY/PA, Boston, Philadelphia, or SF Bay Area, CA preferred (Remote)

Function: Product Management Clinical Data Standards and Statistical Programming

Role Type: Client-facing product strategy, integration, validation, and release ownership

About Saama

Saama is an AI and advanced analytics company built for life sciences. Best known for the AI-powered clinical platform that supported the trial behind the world's first COVID-19 vaccine, Saama works with many of the top 20 pharmaceutical companies and a large base of emerging biotechs. Alongside our clinical development portfolio, we operate a growing Commercial business spanning commercial data platforms, master data management, advanced BI, and our Analytics for Commercial Excellence (ACE) solution family serving marketing, sales, market access, and patient services organizations. We are hiring a senior leader to own and scale that Commercial business. The Sr. Director of Product Management will own the strategy, requirements, roadmap, and execution for the Navigator product series, including SDTM Navigator, ADaM Navigator, TLF Navigator, and their evolution into a unified Navigator-X experience. The role will also own the integration of the Navigator products with BRAIN, Agent OS, and related clinical AI capabilities. The individual will define the product whatuser problems, workflows, requirements, priorities, controls, and acceptance criteriawhile partnering with Architecture and Engineering teams on the technical how. This position requires deep understanding of statistical programming, CDISC standards, clinical data transformations, analysis datasets, TLF production, metadata governance, program execution, QC, traceability, and regulated product development.

Key Responsibilities

• Own the product vision, strategy, roadmap, release scope, and backlog for SDTM, ADaM, and TLF Navigator products, including their transition toward an integrated and modular Navigator-X platform.
• Define an end-to-end statistical-programming workflow covering protocol and SAP interpretation, source-data assessment, SDTM mapping, ADaM derivations, TLF specifications, program generation, execution, QC, traceability, approval, and reuse.
• Serve as the statistical-programming and clinical-data product authority, ensuring product capabilities reflect how standards leads, statistical programmers, QC programmers, study leads, and programming-operations leaders perform their work.
• Translate customer and internal stakeholder needs into product requirements, workflow diagrams, epics, user stories, acceptance criteria, release priorities, and measurable product outcomes.
• Define MVP and MVP+ scope by balancing architecture, governance, user experience, existing customer workflows, technical feasibility, and longer-term product strategy.
• Protect continuity for existing users while introducing conversational, natural-language, and agent-assisted workflows. Determine when the current user experience should be enhanced and when new workflow components are required.
• Drive product capabilities involving protocol, SAP, mock-shell and source-data amendments; incremental predictions; historical-study reuse; standards-based specification generation; codelist prediction; reference files; artifact versioning; draft management; and out-of-sync detection.
• Own requirements for SDTM and ADaM specification generation, direct ingestion of specifications and datasets, define.xml-related workflows, P21 and CDISC CORE validation, program generation and execution, concurrent job processing, lineage display, citations, and observability.
• Define TLF Navigator capabilities for interpreting SAPs and mock shells, recommending required outputs, linking outputs to ADaM data and analysis methods, generating specifications and programs, supporting amendments, and checking consistency among SAP text, specifications, code, and final tables, listings, and figures.
• Ensure the unified platform supports configurable SDTM, ADaM, and TLF stages so that each tenant can adopt one or more components without requiring an all-or-nothing implementation.
• Own the Navigator-to-BRAIN integration model, including the controlled transfer of approved specifications, mappings, programs, datasets, outputs, metadata, and reusable assets into BRAIN for execution, QC, versioning, workflow management, and approval.
• Define BRAIN requirements for study and standards setup, metadata management, artifact inventories, production and QC workflows, bulk status changes, dataset comparison, dry runs, version holds, executi