Director, Expertise Centre - R&D; Technologist (Clinical Data Solutions)

The Director - R&D; Technologist (Clinical Data Solutions) provides strategic and scientific leadership across clinical data management, analytics, biostatistics, statistical programming, and clinical data standards.

This role is central to the R&D; Technologist Expertise Centre and focuses on designing and delivering innovative clinical data solutions across the drug development lifecycle - with a strong emphasis on clinical data standards, transformation, and analytics-driven decision-making.

What You'll Do :

- Provide strategic leadership across clinical data management, biometrics, and advanced analytics for end-to-end drug development programs.
- Serve as the go-to leader for clinical data solutions, bringing a strong techno-functional perspective across clinical data flow and systems.
- Lead complex client engagements spanning clinical data strategy, analytics enablement, and digital R&D; transformation.
- Facilitate senior-level workshops to align stakeholders on study design, data standards, analytics approaches, and operating models.

Clinical Data &

- Standards Leadership :
- Bring deep expertise in clinical data standards (e.g., CDISC - CDASH, SDTM, ADaM, TLF).
- Define innovative approaches to clinical data collection, transformation, and analytics.
- Integrate clinical programming, analytics, and data science into trial design, execution, and regulatory workflows.
- Drive adoption of standardized, scalable, and future-ready clinical data models.

Technology &

- Innovation :
- Apply a techno-functional lens across clinical systems, data platforms, and enterprise architectures.
- Leverage AI/ML and GenAI approaches to transform clinical data processing and analytics.
- Define future-state operating models and digital ecosystems for clinical data and analytics.

Delivery Excellence &

- Governance :
- Oversee quality, scientific rigor, and compliance of deliverables, including analytics, data models, and regulatory outputs.




- Ensure alignment with GxP standards, regulatory expectations, and industry best practices.
- Act as a bridge between scientific, business, and engineering teams.

Team &

- Practice Building :
- Lead and grow a high-performing clinical data and analytics team.
- Mentor senior talent and establish standards for delivery excellence.
- Contribute to capability building, accelerators, and new offerings within the Expertise Centre.
- Support business development through solutioning, client pursuits, and long-term relationship building.

What You'll Bring

Experience &

- Domain Expertise :
- 18 years of experience in Life Sciences R&D;, with strong expertise in clinical data management, biometrics, and analytics.
- Deep understanding of the end-to-end drug development lifecycle.
- Strong domain knowledge of clinical data, analytics, and digital R&D; transformation.

Clinical Systems &

- Platforms :
- EDC Platforms : Medidata Rave, Veeva EDC, Oracle InForm.
- Clinical Systems : ePRO, laboratory systems, CTMS, eTMF, CDMS.
- Clinical Data Repositories : SAS LSAF, Oracle LSH, eClinical Elluminate.
- Metadata Repositories : Nurocor, Sycamore, Formedix.
- Statistical Computing : SAS, SAS Viya, Domino.

Data Standards &

- Interoperability :
- CDISC : CDASH, SDTM, ADaM, TLF.
- Interoperability : FHIR, HL7, USDM.

Technical &

- Analytical Skills :
- Working knowledge of R, Python, and SAS for clinical data transformation and analysis.
- Exposure to AI/ML and GenAI-based solutions in clinical data and analytics.
- Strong capability in business process modeling, data flow modeling, and solution architecture design.

Leadership &

- Consulting Skills :
- Strong communication and stakeholder management skills with ability to influence senior leaders.
- Proven experience in GxP-compliant, large-scale enterprise programs.
- Ability to lead global, cross-functional, and multi-vendor teams.
- Robust leadership, mentoring, and team-building capabilities.
- Solid understanding of agile, product-led, and digital transformation delivery models.

📌 Director - Clinical Data Solutions (India)
🏢 Info_Test_ProductTeam
📍 India