Python Developer - Planet Pharma : Job Details

Job DescriptionTarget Pay Rate: 80-100/hr salary will be commensurate with experience About the Role: We 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: • Masters 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. ?CO/NY candidates may not be considered Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.