30 Jul
|
ZS
|
Maharashtra
Director Expertise Center RD Technologist Clinical data solutions
The Director RD 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 RD Technologist Expertise Centre and focuses on designing and delivering innovative clinical data solutions across the drug development lifecyclewith a strong emphasis on clinical data standards, transformation, and analytics-driven decision-making. You will combine deep technical expertise, consulting leadership, and practice-building capabilities to serve as a trusted advisor to senior stakeholders, driving next-generation clinical data and analytics solutions that improve development outcomes and accelerate regulatory submissions
What Youll Do:
Strategic Client Leadership
- Provide strategic leadership across clinical data management, biometrics, and advanced analytics for end-to-end drug development programs
- Serve as ZSs go-to leader for clinical data solutions, bringing a robust techno-functional perspective across clinical data flow and systems
- Lead complex client engagements spanning clinical data strategy, analytics enablement, and digital RD 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 youll bring:
Experience Domain Expertise
- 18+ years of experience in Life Sciences RD, 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 RD transformation
Clinical Systems Platforms
Experience working with:
- 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
- Strong expertise in:
- 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
How youll grow:
- Cross-functional skills development custom learning pathways
- Milestone training programs aligned to career progression opportunities
- Internal mobility paths that empower growth via s-curves, individual contribution and role expansions
📌 Director - R&D Technologist (Maharashtra)
🏢 ZS
📍 Maharashtra