Senior Manager​/Lead Data Scientist; Clinical Data Standardization & ETL Operations

Position: Senior Manager / Lead Data Scientist (Clinical Data Standardization & ETL Operations)
Location: Bengaluru

Position Overview
We are seeking an accomplished  Senior Manager / Lead Data Scientist  to lead a high-performing team of data scientists and engineers focused on clinical data standardization, ETL workflows, and regulatory-ready data products. This leadership role requires deep expertise in  CDISC standards (SDTM, ADaM, TLFs) ,  OMOP Common Data Model , and  genomic variant data , combined with proven ability to guide technical teams, architect scalable ETL pipelines, and ensure regulatory compliance across real-world data (RWD), EHR systems, and clinical trial datasets.
The ideal candidate will drive the strategic direction of our clinical data operations, mentor a diverse team of data professionals, and serve as the primary technical authority for OMOP/SDTM transformations and regulatory submissions to agencies such as the FDA and PMDA.

Key Responsibilities Leadership & Strategy

· Lead, mentor, and develop a team of data scientists, data engineers, and analysts working on clinical data standardization and ETL workflows

· Define and execute the technical roadmap for OMOP and CDISC-compliant data pipelines, ensuring alignment with business objectives and regulatory requirements

· Foster a culture of technical excellence, continuous improvement, and collaborative problem-solving across multidisciplinary teams

· Partner with senior leadership to shape data strategy for precision medicine, regulatory submissions, and real-world evidence generation

· Drive adoption of best practices in metadata-driven automation, reproducible workflows, and quality assurance frameworks

Technical Architecture & Delivery

· Design and oversee end-to-end ETL architectures for converting heterogeneous clinical, EHR, and real-world data sources into  OMOP CDM ,  SDTM ,  ADaM , and  TLF  formats

· Establish and maintain production-grade pipelines using open-source workflow orchestration tools (Airflow, Prefect, Nextflow, Luigi) and proprietary systems (SAS DI, Informatica, cloud-native platforms)

· Champion the use of  OHDSI tools  (White Rabbit, Rabbit-in-a-Hat, ETL-CDMBuilder, Achilles, Data Quality Dashboard ) for OMOP transformations and quality validation

· Ensure adherence to  CDISC 360  metadata standards, Define.xml generation, controlled terminology management, and SDTM/ADaM conformance

· Implement robust data quality, validation, and reconciliation processes across all stages of ETL, leveraging Pinnacle 21 and custom QC frameworks

Regulatory & Compliance

· Serve as the subject matter expert for regulatory submission-ready datasets, ensuring timely and accurate delivery of SDTM/ADaM/TLFs to FDA, EMA, and PMDA

· Collaborate with biostatistics, clinical operations, regulatory affairs, and quality assurance teams to meet submission timelines and compliance standards

· Provide expert guidance on data privacy, security, and governance in alignment with HIPAA, GDPR, ICH GCP, and ISO 27001/27701 standards

· Review and approve Define.xml, Reviewer's Guides, aCRFs, and other submission documentation for regulatory packages

Genomic & Variant Data Specialization

· Lead initiatives for curating, harmonizing, and annotating genomic variant datasets from public and proprietary sources (Clin Var, Clin Gen, HGMD, CADD, gnom

AD, dbSNP, COSMIC, refSeq, REVEL)

· Oversee ETL pipelines for mapping VCF annotation files to OMOP genomic tables and CDISC submission formats

· Ensure quality control of variant annotations, reference genome build consistency (GRCh
37/38), and adherence to HGVS nomenclature

· Stay current with emerging variant annotation standards, genomic data formats (VCF, BED, GFF), and translational research methodologies

Stakeholder Engagement

· Act as the primary liaison between technical teams, clinical operations, statistical programming, and external partners on data standards and interoperability

· Translate complex technical challenges into business-friendly solutions and communicate risks, trade-offs, and opportunities to senior stakeholders

· Represent the organization in industry forums, CDISC working groups, OHDSI community events, and regulatory interactions

Required Qualifications Education

· Ph.D.  in Bioinformatics, Health…