CDISC Expert (EDC → SDTM → ADaM) | Oncology | R Only -- 2

₹400-750 INR / time

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Slået op 24 dage siden

₹400-750 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: 40241570

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Aktiv 23 dage siden

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2 freelancere byder i gennemsnit ₹538 INR/time på dette job

@amiteshs20

It is an important role and I had many more qualifications related to this job. Iam skilled in Data processing statistical analysis as well as in research and data management

₹575 INR på 40 dage

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@hassam945

Hi there, With my background in Software Engineering fortified by extensive experience in AI, ML, Data Science, and Computer Vision, I can contribute significantly to your team's CDISC needs. Over the years, I have worked closely with clinical data, crafting intelligent systems from raw data preprocessing to model training and deployment. I specialize in multiple domains including 3D medical imaging and time-series forecasting, making me versatile for any task thrown at me. To put your mind at ease, I am not only well-versed in CDISC standards, but I am also comfortable conducting all SDTM and ADaM development exclusively in R. This aligns perfectly with your requirements for an expert consultant who can enable your Pune team to operate fully within R workflows. Let my proficiency with a wide range of tools like Flask, Streamlit, and Gradio prove that I can make this process efficient and reliable for you. Versatility is essential in the field of AI and Machine Learning; and my portfolio display this. From healthcare projects such as developing a system for Diabetic Retinopathy Classification to NLP Sentiment Analysis for emotion detection and customer feedback analytics, all the way to object detection pipelines for real-world vision tasks; I have continuously delivered highly quantitative solutions using structured reviews. That same dexterity will be invaluable throughout our collaboration on this project.

₹500 INR på 30 dage