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.

- Strong leadership, mentoring, and team-building capabilities.

- Solid understanding of agile, product-led, and digital transformation delivery models.