Lead R&D Technologist - Clinical Business Analyst (Clinical Data Solutions)

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS.
About ZS R&D (Life Sciences)
ZS life science R&D team partners with clients to discover and develop innovative medicines that improve patient's lives. Our work spans consulting, analytics and technology (services and platforms) projects across the several domains. We have 3500+ zs professionals that deliver R&D programs, $100MM+ invested in R&D data, analytics and technology assets and 100+ clients on R&D programs.
About the Expertise Centre - R&D Technologist
The R&D Technologist Expertise Centre within ZS's Drug Development practice partners with biopharma organizations to design and deliver innovative clinical data solutions that accelerate drug development and reduce risk from portfolio to patient.
The team operates at the intersection of key ZS drug development verticals-including asset strategy, clinical trial design, clinical data management, statistical programming, regulatory, and risk-based quality.
By combining deep clinical domain expertise, data standards, clinical programming, systems understanding, and consulting discipline, the team solves complex R&D challenges with speed, scale, and measurable impact.
What You'll Do:
Business Analysis Leadership & Agile Delivery

• Lead BA activities within Agile teams (Scrum / SAFe / Kanban) and act as the primary requirements owner for assigned workstreams.

• Drive discovery: plan and facilitate workshops, stakeholder interviews, and requirement walkthroughs with clinical, biometrics, data management, and technology teams.

• Convert complex clinical and business needs into clear deliverables (epics, features, user stories, acceptance criteria) with strong testability and traceability (RTM).

• Partner with Product Owners to shape the backlog (prioritization, refinement, scope management) and support sprint ceremonies (planning, reviews, retrospectives).

• Identify risks, dependencies, and gaps early; propose options and recommendations, and support timely decision-making.

• Mentor Associate Consultants / BAs on best practices for story writing, requirement quality, and stakeholder management.

Clinical Data Hub & Repository Programs

• Lead requirements and solution definition for clinical data hubs/repositories, including source onboarding (EDC, Labs, eCOA , Imaging, Safety) and downstream consumption.

• Define data ingestion, mapping, transformation, reconciliation, and access-control requirements; ensure alignment with data governance expectations.

• Collaborate with architects/engineering to validate data flows, metadata strategy, and quality controls in GxP -compliant environments.

• Support UAT strategy, test scenario design, defect triage, and release readiness for repository/platform deployments.

Clinical Data Products & AI-Driven Automation

• Own functional requirements for clinical data products and automation initiatives (e.g., SDTM/ ADaM enablement, mapping accelerators, automated checks, reusable analytics components).

• Translate clinical/biometrics needs into automation use cases, ensure measurable acceptance criteria, and align stakeholders on expected outcomes.

• Work with data science/engineering teams to define training/validation datasets, quality thresholds, and operational workflows (human-in-the-loop, auditability).

Statistical & risk based clinical data review

• Lead requirement definition for centralized/statistical monitoring solutions, including metrics, signals, dashboards, reports, and operational workflows for study oversight.

• Partner with statisticians, clinical operations, and quality stakeholders to ensure monitoring logic is transparent, testable, and fit for purpose.

Stakeholder Collaboration & Delivery Management

• Serve as the day-to-day BA lead for client and internal stakeholders; manage expectations and ensure clarity of scope, decisions, and documentation.

• Coordinate with Engineering, AI, CDM, and Product teams to ensure requirements are feasible, complete, and aligned to target architecture.

• Maintain high-quality project artefacts (BRD/FRD, user stories, process flows, data flows, traceability, release notes) and support audits as needed

What You'll Bring:
Experience & Domain Expertise

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Statistics, Data Science, Engineering, Computer Science, or a related field.
• 7 - 12 years of experience in Life Sciences R&D
• Understanding of the end-to-end drug development lifecycle
• Strong domain knowledge in life sciences in either of the following domain: discovery/pre-clinical, clinical, regulatory
• Proven experience leading requirements end-to-end in Agile delivery (story mapping, backlog management, sprint execution support).
• Excellent communication, facilitation, and stakeholder management skills.

Clinical Systems & Platforms
Good to have 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
Good to have Expertise in:

• CDISC: CDASH, SDTM, ADaM, TLF
• Interoperability: FHIR, HL7, USDM

Technical & Analytical Skills
Good to have:

• Working knowledge of R, Python, and SASfor clinical data transformation and analysis
• Exposure to AI/ML and GenAI-based solutionsin clinical data and analytics
• Strong capability in business process modeling, data flow modeling, and solution architecture design

How you'll 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

Perks & Benefits:
At ZS, your growth matters. We offer a comprehensive total rewards package that supports your health and well-being, financial future, time away, and professional development. With robust skills-building programs, multiple career progression paths, internal mobility, and a deeply collaborative culture, you'll have the opportunity to do meaningful work, expand your capabilities, and thrive as part of a global community. For details on total rewards in India , visit ZS India office locations | Where we work | ZS .
Hybrid working model:
We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.
Travel:
Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.
Considering applying?
At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems-the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. Learn more about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive.
If you're eager to grow, contribute, and bring your unique self to our work, we encourage you to apply.
ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.
To complete your application:
Candidates must possess or be able to obtain work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.
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www.zs.com