CDISC Expert (EDC → SDTM → ADaM) | Oncology | R Only

₹100-400 INR / time

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Slået op 17 dage siden

₹100-400 INR / time

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 [login to view URL] 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)

Projekt-ID: 40241545

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Aktiv 14 dage siden

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2 freelancere byder i gennemsnit ₹300 INR/time på dette job

@hassam945

Hi, With over 5 years of exemplary experience in delivering SDTM + ADaM from EDC/raw clinical data, I am confident that my expertise aligns perfectly with your project requirements. Not only do I have a strong grasp of CDISC and SDTMIG + ADaMIG best practices, but I am also comfortable with R as the primary/only implementation language for SDTM/ADaM development. My hands-on experience in the Oncology domain, particularly solid tumors and hematologic malignancies, further substantiates my suitability for this role. What sets me apart is my holistic understanding of AI and ML development: from raw data preprocessing and analysis to model training, optimization, and finally deployment in a clean architecture with optimized performance. This background enables me to build intelligent systems in adherence to best practices that can effectively extract meaningful information from your EDC data. Furthermore, being well-versed in modern workflows of R will ensure high-quality guidance and skill enhancement support for your team. As a remote consultant working closely with your Pune-based team, I’m equipped to deliver results during Indian working hours through recurring sessions and asynchronous support. In essence, choosing me would mean gaining an experienced professional who can seamlessly enable your team to become self-sufficient in building powerful clinical data workflows while staying aligned with set standards.

₹350 INR på 40 dage