Job Description
Are you a detail-oriented data expert passionate about accelerating life-saving therapies?
NexGen BioSolutions is seeking a visionary **Senior Clinical Data Analyst** to join our dynamic team in Boston. In this pivotal role, you will bridge the gap between complex clinical trials and actionable insights, ensuring data integrity across global studies. We offer a competitive salary, comprehensive health benefits, and the opportunity to work on breakthrough treatments.
If you thrive in a fast-paced regulatory environment and possess a knack for problem-solving, we want to hear from you.
NexGen BioSolutions is seeking a visionary **Senior Clinical Data Analyst** to join our dynamic team in Boston. In this pivotal role, you will bridge the gap between complex clinical trials and actionable insights, ensuring data integrity across global studies. We offer a competitive salary, comprehensive health benefits, and the opportunity to work on breakthrough treatments.
If you thrive in a fast-paced regulatory environment and possess a knack for problem-solving, we want to hear from you.
Responsibilities
- Design and implement data management strategies for Phase I-IV clinical trials.
- Ensure strict adherence to Good Clinical Practice (GCP) and regulatory standards.
- Perform data validation, cleaning, and analysis using SQL and statistical programming languages.
- Collaborate cross-functionally with Clinical Operations, Medical Writing, and Regulatory Affairs teams.
- Lead the creation of Data Review Plans (DRP) and Data Monitoring Reports.
- Mentor junior analysts and contribute to process improvement initiatives.
- Manage data queries and resolve discrepancies with external vendors and investigators.
Qualifications
- Master’s degree in Biostatistics, Data Science, Pharmacy, or a related Life Sciences field.
- Minimum of 5 years of experience in clinical data analysis within the pharmaceutical industry.
- Advanced proficiency in SQL, SAS, and/or R programming languages.
- Strong understanding of CDISC standards (SDTM, ADaM) is highly preferred.
- Proven track record of managing data integrity and quality assurance processes.
- Excellent verbal and written communication skills for stakeholder reporting.