Lead Analyst Bio Statistician, Clinical Research

About the role

This position provides statistical guidance for clinical research programs and individual studies within a multidisciplinary team. The role involves developing Statistical Analysis Plans, creating derived variables, and performing data analysis to meet business needs.

Key responsibilities

• Develop and execute statistical analysis plans, including methodology, data‑handling rules, and mockups.
• Collaborate with project teams to define timelines, study designs, endpoints, and analysis strategies.
• Perform inferential analyses, generate tables, listings, and graphs, and support regulatory submissions.
• Guide junior programmers/statisticians and ensure quality control of SAS programs and datasets.

Required profile

• MS or PhD in statistics, biostatistics, mathematics or related field.
• 6‑9 years of relevant experience, preferably in medical device, pharmaceutical or biotechnology clinical trials.
• Strong understanding of regulatory guidelines (FDA/CFR, ISO14155) and clinical trial design.
• Excellent communication skills and ability to explain statistical concepts to non‑statisticians.

Required skills

• SAS programming (including macros, SQL integration, and advanced data manipulation).
• Statistical methods such as non‑parametric analysis, linear/non‑linear models, categorical data, and survival analysis.
• Experience with electronic data capture (EDC) and electronic health records (EHR) systems.
• Proficiency in creating derived variables (e.g., LOCF) and handling adverse event datasets.