Principal Biostatistician

The role

The Principal Biostatistician provides statistical support for all phases of clinical development. This role involves writing protocols and analysis plans, conducting statistical analyses, and developing SAS programs.

What you will do

• Generate and verify randomization schedules
• Develop and review statistical methods of the clinical study protocol
• Provide and verify sample size calculations
• Provide input into development of case report forms
• Author statistical analysis plans
• Review statistical analysis plans written by other biostatisticians
• Generate analysis datasets, tables, figures, and listings using SAS
• Perform quality control for statistical based SAS programs and other study documents
• Provide or supervise programming and statistical support for regulatory agencies or ad-hoc requests
• Provide statistical analysis and reports to Data Monitoring Committees

Required qualifications

• Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience
• PhD degree in Statistics, Biostatistics, or related field with 7+ years experience
• Experience with SAS
• Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
• Broad knowledge and superior understanding of advanced statistical concepts and techniques
• Mastery of statistical principles underlying clinical trials
• Mastery of SAS programming skills and familiarity with other packages
• Outstanding statistical skills
• Excellent consultative skills
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
• Excellent communication and interpersonal skills
• Excellent problem-solving skills

Nice to have

• Experience with Oncology and rare diseases
• Broad experience with late phase and/or submissions
• Experience in consulting with clients on study design
• Superior understanding of a specific therapeutic area and/or statistical methodology (eg, adaptive design, missing data)

Before you apply

• Candidates must be legally authorized to work in the country of employment without employer sponsorship

About the company

Precision Medicine Group is an Equal Opportunity Employer.