CDISC Expert (EDC → SDTM → ADaM) | Oncology | R Only -- 2
Budget: ₹400 – ₹750 INR
We’re an AI-first team building modern clinical data workflows at the intersection of pharmaceuticals and AI. We’re seeking an experienced CDISC consultant to enable and mentor our internal team in Pune to build oncology SDTM and ADaM from EDC data, using R only. This is an expert-guidance role (standards, reviews, and coaching), with hands-on support to help the team become self-sufficient.
What you’ll do (expert + enablement)
Act as the SDTM/ADaM oncology SME for the internal Pune team.
Define a repeatable, scalable EDC → SDTM → ADaM approach: standards, templates, conventions, traceability.
Create/review:
SDTM mapping specs (EDC → SDTM domains/variables)
ADaM derivation specs (ADSL + key efficacy/safety ADaMs)
QC/validation checks and common issue playbooks
Run working sessions and reviews (spec reviews, dataset reviews, derivation logic reviews).
Collaborate with engineering so the workflow is automation-ready and consistent across studies.
Requirements
5+ years hands-on experience delivering SDTM + ADaM from EDC/raw clinical data.
Strong CDISC expertise: SDTMIG + ADaMIG best practices.
Oncology trial experience (solid tumors and/or hematologic malignancies).
R as the primary/only implementation language for SDTM/ADaM development (comfortable with modern R workflows).
Strong communication and mentoring skills; able to guide a team via structured reviews.
Preferred
RECIST, tumor assessment/response workflows, time-to-event endpoints.
Familiarity with validation tooling (e.g., Pinnacle 21 or equivalent) and define.xml expectations.
Working model
Remote consultant working closely with a Pune-based team.
Regular overlap with India working hours (recurring sessions + async support).
To apply, please share
Brief summary of your SDTM/ADaM + oncology experience (and the scale you’ve supported)
Confirmation you can support R-only development
Availability (hours/week) and hourly rate (or fixed-bid proposal)
High-level examples of domains/ADaMs you’ve worked on (no confidential data)
What you’ll do (expert + enablement)
Act as the SDTM/ADaM oncology SME for the internal Pune team.
Define a repeatable, scalable EDC → SDTM → ADaM approach: standards, templates, conventions, traceability.
Create/review:
SDTM mapping specs (EDC → SDTM domains/variables)
ADaM derivation specs (ADSL + key efficacy/safety ADaMs)
QC/validation checks and common issue playbooks
Run working sessions and reviews (spec reviews, dataset reviews, derivation logic reviews).
Collaborate with engineering so the workflow is automation-ready and consistent across studies.
Requirements
5+ years hands-on experience delivering SDTM + ADaM from EDC/raw clinical data.
Strong CDISC expertise: SDTMIG + ADaMIG best practices.
Oncology trial experience (solid tumors and/or hematologic malignancies).
R as the primary/only implementation language for SDTM/ADaM development (comfortable with modern R workflows).
Strong communication and mentoring skills; able to guide a team via structured reviews.
Preferred
RECIST, tumor assessment/response workflows, time-to-event endpoints.
Familiarity with validation tooling (e.g., Pinnacle 21 or equivalent) and define.xml expectations.
Working model
Remote consultant working closely with a Pune-based team.
Regular overlap with India working hours (recurring sessions + async support).
To apply, please share
Brief summary of your SDTM/ADaM + oncology experience (and the scale you’ve supported)
Confirmation you can support R-only development
Availability (hours/week) and hourly rate (or fixed-bid proposal)
High-level examples of domains/ADaMs you’ve worked on (no confidential data)
Related categories:
Data Processing
Research
Statistical Analysis
Data Science
Data Management
Biostatistics