Job Description
Join our pioneering healthcare analytics team at MedTech Solutions, where we transform raw medical data into life-saving insights. We're seeking a Senior Clinical Data Analyst to drive evidence-based decision-making in cutting-edge clinical research. This role combines statistical rigor with healthcare domain expertise to accelerate therapeutic innovations. You'll collaborate with cross-functional teams including biostatisticians, physicians, and regulatory specialists to ensure data integrity and regulatory compliance throughout clinical trials.
Our Boston-based hub offers state-of-the-art facilities, flexible work arrangements, and competitive benefits including comprehensive health coverage and professional development stipends. Shape the future of precision medicine while working with industry-leading EHR systems and AI-powered analytics platforms.
Responsibilities
- Design and implement statistical analysis plans for multi-center clinical trials using SAS/R
- Validate and clean complex clinical datasets from EHRs and electronic data capture systems
- Generate regulatory-compliant analysis datasets and clinical study reports
- Lead data quality initiatives and ensure compliance with FDA 21 CFR Part 11 requirements
- Develop interactive dashboards for real-time trial monitoring and safety signal detection
- Mentor junior analysts and optimize data processing workflows
- Present findings to executive stakeholders and regulatory authorities
Qualifications
- Master's degree in Biostatistics, Epidemiology, or related quantitative field
- 5+ years of clinical data analysis experience in pharmaceutical or medical device setting
- Expert proficiency in SAS (Base, Macros) and R programming with tidyverse
- Certified Clinical Data Manager (CCDM) or equivalent preferred
- Deep understanding of clinical trial phases and regulatory frameworks (ICH-GCP, FDA)
- Experience with CDISC standards (SDTM, ADaM) and Medidata Rave
- Strong problem-solving skills with ability to handle ambiguous datasets