Business Analyst - Clinical Data & TFL Submission Package

Job description:

We are seeking a data-driven Business Analyst specializing in TFL (Tables, Figures, and Listings) Submission Packages to bridge the gap between clinical data operations, biostatistics, and regulatory affairs. In this role, you will define requirements, map data workflows, and ensure that all clinical trial documentation complies with global regulatory standards (FDA, EMA, PMDA) using CDISC models (SDTM, ADaM). You will be responsible for translating complex statistical analysis plans into actionable specifications for programming teams, ensuring flawless regulatory submission deliverables.

Key Responsibilities

• Requirement Gathering & Management: Collaborating with Biostatisticians, Clinical Data Managers, and Medical Writers to gather, document, and manage business requirements for TFL generation.
• TFL Shell Specification: Translating Statistical Analysis Plans (SAP) into detailed functional specifications and mock-ups (shells) for Tables, Figures, and Listings.
• Data Mapping & Lineage: Creating and maintaining data specification documents, ensuring seamless traceability from raw clinical data (EDC) to SDTM, ADaM, and final TFL outputs.
• Submission Readiness: Overseeing the assembly, validation, and quality control of the final TFL package component of the Common Technical Document (CTD) for regulatory submissions (NDA/BLA/MAA).
• Cross-Functional Liaison: Serving as the primary interface between clinical study teams and statistical programming teams to resolve data discrepancies and formatting issues.
• Process Optimization: Documenting and standardizing standard operating procedures (SOPs) to streamline the TFL development lifecycle and reduce submission cycle times.

Required Qualifications

• Experience: 3–5+ years of experience as a Business Analyst within the pharmaceutical, biotech, or Clinical Research Organization (CRO) industries.
• Domain Knowledge: Strong understanding of the clinical trial lifecycle, clinical data management, and the structure of regulatory submission packages.
• CDISC Standards: Solid working knowledge of CDISC standards, specifically SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model).
• Technical Skills: Proficiency in writing technical requirements, data mapping specifications, and using data visualization or profiling tools. Familiarity with SAS or R programming concepts is highly preferred.
• Documentation: Proven experience creating high-quality Business Requirement Documents (BRDs), Functional Specifications, and TFL mock-shells.
• Education: Bachelor’s degree in Life Sciences, Health Informatics, Computer Science, Statistics, or a related field