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Key Responsibilities and Required Skills for Global Clinical Data Standards Therapeutic Area Lead

💰 $ - $

Clinical DataData StandardsTherapeutic Area Leadership

🎯 Role Definition

The Global Clinical Data Standards Therapeutic Area Lead is a senior cross-functional leader responsible for defining, implementing and governing clinical data standards across a therapeutic area portfolio. This role owns the therapeutic-area-specific data standards strategy (CDISC SDTM/ADaM/CDASH), controlled terminology, metadata and mappings required for analysis-ready clinical trial data and regulatory submissions. The Lead partners with clinical operations, biostatistics, medical writing, regulatory affairs, clinical programmers and external vendors to ensure consistent, scalable and compliant data standards, tooling, and processes for global studies.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Data Manager with data standards or CDISC experience
  • Clinical Programmer / Biostatistics Programmer experienced in SDTM/ADaM
  • Data Standards Specialist or Metadata Manager within pharma/biotech

Advancement To:

  • Head of Clinical Data Standards
  • Global Head of Biometrics / Data Operations
  • Director, Clinical Data Strategy or Head of R&D Data Standards

Lateral Moves:

  • Therapeutic Area Data Governance Lead
  • Clinical Metadata Repository (MDR) Manager

Core Responsibilities

Primary Functions

  • Lead the development, maintenance and continuous improvement of therapeutic-area-specific data standards and implementation guides, including CDISC SDTM, ADaM, CDASH and Controlled Terminology, ensuring alignment with company-wide and industry standards (ICH, FDA/EMA expectations).
  • Define and manage the end-to-end data standards strategy for the therapeutic area, prioritizing standards harmonization, reusability and scalability across global studies and phases (I–IV).
  • Author, review and approve therapeutic area-specific metadata, CRF annotations and SDTM/ADaM mapping specifications to ensure analysis-ready datasets for statistical programming and regulatory submission packages.
  • Own the therapeutic area content in the company’s Metadata Repository (MDR), ensuring accurate, version-controlled implementation guides, dataset specifications and controlled terminology are available to study teams and vendors.
  • Provide subject matter expertise to cross-functional study teams (clinical operations, biostatistics, medical writing, data management, safety) on data standardization decisions and clinical data design choices to optimize downstream analysis and regulatory acceptability.
  • Design and implement governance processes for therapeutic area-specific standards—change control, versioning, exceptions, and sign-off workflows—to ensure traceability and audit readiness for regulatory inspections and submissions.
  • Partner with biostatistics and programming leads to translate analysis requirements into ADaM dataset designs and derivation rules; oversee alignment on analysis variable definitions, ADSL design and record-level traceability from raw CRF to analysis datasets.
  • Review and approve CRF designs, eCRF specifications and module-level CDASH mapping to mitigate rework and ensure SDTM-ready data capture from study start.
  • Lead or participate in data standards review boards, cross-therapeutic working groups and external industry consortia to harmonize therapeutic area practices and contribute to public CDISC/industry standards where appropriate.
  • Provide hands-on oversight and quality assurance of SDTM/ADaM datasets and define.xml files prepared by internal teams and CROs; establish checklists and acceptance criteria for dataset delivery.
  • Establish and track key performance indicators (KPIs) for standards adoption, submission readiness, dataset quality, and re-use of therapeutic area components across studies.
  • Develop and maintain templates, exemplar mapping documents, ADaM shells and SDTM domain examples specific to the therapeutic area to accelerate study start-up and ensure consistency.
  • Lead vendor selection and management for standards-related services (CRO programming, MDR implementations, controlled terminology services); define SOWs, acceptance criteria and SLA metrics tied to data standards deliverables.
  • Implement automation and tooling strategies (mapping transformation scripts, validation tools, define.xml generators) to improve efficiency and reduce manual effort in dataset production and QC.
  • Coach and mentor clinical data standards specialists, programmers and data managers in therapeutic-area-specific requirements; build a community of practice across global sites and outsourced partners.
  • Provide expert support for regulatory interactions related to data standards, including submission readiness checks, regulatory queries on dataset content and participation in agency meetings as needed.
  • Conduct periodic audits and post-submission reviews to capture lessons learned, drive corrective actions and update therapeutic area standards and implementation procedures.
  • Collaborate with safety/pharmacovigilance teams to align on ADaM/SDTM representations of adverse events, exposure and lab findings to support integrated safety analyses.
  • Translate therapeutic area scientific knowledge into practical data model decisions (e.g., domain splits, specialized domains, timing variables) to reflect disease-specific endpoints and biomarkers correctly.
  • Drive cross-functional training programs, create training materials, and deliver workshops to ensure global study teams and vendors understand therapeutic area standards, controlled terminology and submission expectations.
  • Stay current with evolving industry regulations, CDISC releases, and technology trends; recommend and plan standards upgrades and migrations to new CDISC versions or company-wide MDR implementations.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis.
  • Contribute to the organization's data strategy and roadmap.
  • Collaborate with business units to translate data needs into engineering requirements.
  • Participate in sprint planning and agile ceremonies within the data engineering team.

Required Skills & Competencies

Hard Skills (Technical)

  • Deep expertise in CDISC standards (SDTM, ADaM, CDASH) and experience producing submission-ready datasets and define.xml for FDA/EMA/Health Authority filings.
  • Proven experience authoring and maintaining therapeutic-area-specific implementation guides, metadata and dataset specifications in a Metadata Repository (MDR).
  • Strong knowledge of controlled terminology management and use of CDISC Terminology and codelists; experience with terminology mapping and maintenance.
  • Hands-on experience with statistical programming languages and tools (SAS, R) used to produce ADaM datasets and analysis programs.
  • Familiarity with data conversion and ETL processes from eCRF/EDC to SDTM and ADaM including mapping specification development, transformation logic and reconciliation practices.
  • Experience with data standards validation and quality control tools (e.g., Pinnacle 21, Define-XML validators) and ability to interpret validation reports and coordinate remediation.
  • Demonstrated capability with metadata and dataset documentation standards such as define.xml, ADaM Metadata, and controlled terminology export/import.
  • Knowledge of regulatory requirements and expectations for data submissions (CTD, eCTD components, submission formats) and audit/inspection readiness for clinical data.
  • Experience with clinical trial systems and data sources: EDC, ePRO, IRT/IXRS, lab/vendor feeds, and integrations for SDTM population.
  • Exposure to clinical study design and therapeutic area-specific endpoints, biomarkers, and outcome measures to translate clinical concepts into data model elements.
  • Experience managing external vendors/CROs for programming and data standards delivery with clear SOWs and quality gates.
  • Familiarity with metadata repository solutions (open-source or commercial) and experience supporting migrations or upgrades.
  • Understanding of APIs, scripting and automation approaches to accelerate mapping, dataset generation and quality checks.

Soft Skills

  • Strong leadership and stakeholder management — ability to influence cross-functional and global teams, including senior clinical, statistical and regulatory stakeholders.
  • Excellent written and verbal communication, able to produce clear implementation guides, training materials, and executive summaries.
  • Strategic thinker with the ability to translate organizational goals into practical standards and roadmaps for a therapeutic area.
  • Problem-solving mindset with attention to detail and commitment to data quality and regulatory compliance.
  • Collaborative mindset and facilitation skills for working in global multi-disciplinary project teams.
  • Coaching and mentoring ability to grow capability across internal colleagues and outsourced partners.
  • Comfortable with ambiguity and able to prioritize competing requests in a fast-paced clinical development environment.
  • Change management experience to lead adoption of new standards, tools and processes across the therapeutic area.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in Life Sciences, Biostatistics, Computer Science, Health Informatics or related field.

Preferred Education:

  • Master’s degree or higher in Biostatistics, Epidemiology, Data Science, Biomedical Sciences or related field.
  • Additional certification or formal training in CDISC standards (e.g., CDISC courses, vendor workshops) is advantageous.

Relevant Fields of Study:

  • Biostatistics
  • Clinical Data Management
  • Data Science / Health Informatics
  • Life Sciences / Pharmacology

Experience Requirements

Typical Experience Range:

  • 8–15+ years in clinical data, biostatistics or clinical programming roles with progressive responsibility in data standards.

Preferred:

  • 10+ years with demonstrable experience leading clinical data standards at a global level for one or more therapeutic areas, including direct experience with regulatory submissions and vendor management.
  • Proven track record implementing CDISC (SDTM/ADaM/CDASH) for multiple late-phase and submission-ready clinical trials.
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