Principal Biostatistician

Responsibilities

• Provide high-level consulting for statistical analysis, reporting, and programming activities for clinical trials
• Develop and finalize statistical analysis plans, randomization schedules, and study protocols
• Act as study statistician by interacting with clients and clinical teams including programmers and data managers
• Mentor and perform quality control on statistical programmer outputs and define analysis data specifications
• Develop SAS programs to generate analysis datasets, tables, listings, and graphs (TLGs)
• Analyze data to support trial progression decisions, including blinded data reviews and interim analyses
• Collaborate with teams for regulatory reviews and support ad-hoc or post-hoc analyses
• Ensure compliance with industry quality standards, ICH guidelines, GCP, and 21 CFR Part 11

Requirements

• 10+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting/SAS programming roles
• Strong experience in clinical study design, analysis, and sample size determination
• Expertise in developing randomization schedules and IVRS specifications
• Deep knowledge of CDISC models including SDTM and ADaM
• Proficiency in SAS programming for clinical trial reporting
• Strong knowledge of ICH guidelines, GCP, and 21 CFR Part 11 (FDA/EMEA)
• Knowledge of coding dictionaries such as MedDRA, WHO, COSTART, or ICD-9
• Excellent English communication skills (written and verbal)

Preferred Qualifications

• Master's degree in Statistics or Biostatistics
• SAS certification

About the Company

eClinical Solutions helps life sciences organizations accelerate clinical development initiatives through expert data services and the elluminate Clinical Data Cloud. The company is a recognized leader in digital trials and a winner of the Top Workplaces USA Award for Remote Work.