Hi All,
Please find below mentioned job description.
Job Title- Python Pharmaceutical Developer
Visa- Any
Duration- 12+ Months
Interview- Virtual
Client Location- Pittsburgh, PA Onsite
Role: Job Responsibilities 100% remote EST time zoneTop 3:Must already be familiar with SDTM/CDISC clinical data standardsMUST have pharma environment/industry experience.Previous experience implementing scalable AI solutions is idealAbout the RoleWe are seeking a talented Python Developer with experience in clinical data standards (SDTM/CDISC) and a passion for AI/ML-driven automation. In this role, you will design and implement scalable solutions to automate the transformation of raw clinical trial data into SDTM-compliant datasets, reducing manual effort and increasing efficiency.Key Responsibilities• Design and develop automation pipelines for SDTM dataset generation using Python.• Build and deploy AI/ML models to streamline data mapping, domain identification, and controlled terminology matching.• Automate metadata-driven data transformations based on CDISC/SDTM standards.• Collaborate with cross-functional teams (clinical programming, data management, biostats) to gather requirements and ensure regulatory compliance.• Create reusable Python libraries and tools to support automation across multiple studies.• Implement validation checks, quality controls, and audit trails to ensure SDTM compliance and traceability.• Stay current with CDISC standards, regulatory guidelines (e.g., FDA), and AI/ML best practices.Required Qualifications• Master’s degree with 8+ years of experience in clinical or pharma settings and 3+ years of experience in Python development• Strong understanding of SDTM standards and CDISC requirements.• Experience with AI/ML techniques, including data preprocessing, classification, and NLP (e.g., for mapping clinical terms).• Familiarity with tools like Pinnacle 21, Define.xml, and clinical trial data structures.• Excellent problem-solving and collaboration skills.• Experience working with clinical trial datasets (ADaM, SDTM, raw).• Prior work on automation frameworks or metadata-driven data pipelines.• Knowledge of regulatory submission processes and FDA expectations for e-submissions.
Thanks & Regards
Vicky Yadav
Sr. Technical Recruiter
Contact -201-354-2897
Email –
vicky.y@wonese.com” style=”border: 0px; font: inherit; margin: 0px; padding: 0px; vertical-align: baseline;”>vicky.y@wonese.com
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