Key skills

Clinical trial processesClinical Metadata Repositories (MDR)CDISC standards SDTMCDISC standards ADaMCDISC standards CDASHCDISC standards CTRegulatory submissions and compliance FDARegulatory submissions and compliance EMAData modelsMetadata schemasMetadata mappingsGraph databasesMetadata servicesTechnical designsAPIsJiraConfluenceMicrosoft WordMicrosoft ExcelFigmaVisioSQLStakeholder managementRepositoryStakeholder ManagementCommunication

About this role

SIRO Clinpharm Pvt. Ltd. is looking for a Statistical Programmer/Meta Data Repository Business Analyst. The role requires a strong understanding of clinical trial processes and data lifecycle, along with hands-on experience with Clinical Metadata Repositories and CDISC standards.

Requirements:

Strong understanding of clinical trial processes and data lifecycle
Hands‑on experience with Clinical Metadata Repositories (MDR)
CDISC standards (SDTM, ADaM, CDASH, CT)
Knowledge of regulatory submissions and compliance (FDA, EMA)
Experience working with data models, metadata schemas, and mappings
Familiarity with MDR‑related platforms or technologies (e.g., graph DBs, metadata services)
Ability to read and collaborate on technical designs and APIs (functional perspective)
Requirements & documentation: Jira, Confluence, Word, Excel
Design & validation: Figma, Visio
Data & metadata concepts: SQL (read‑level understanding preferred)
Excellent communication and stakeholder management skills
Strong analytical and problem‑solving mindset
Ability to work in cross‑functional, global teams
Detail‑oriented with a structured, quality‑first approach
Experience working on enterprise MDR implementations
Exposure to standards automation, up‑versioning, or data reuse initiatives