Principal Statistician Consultant-R&I (Respiratory & Immunology) REMOTE@US
Related skills
sas biostatistics clinical trials regulatory respiratory immunology📋 Description
- Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
- Provide statistical oversight to studies ensuring quality and alignment with project requirements.
- Ensure data for statistical analyses are complete, accurate and consistent.
- Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
- Demonstrate extensive understanding of statistical concepts and methodologies; identify and correct flaws in interpretation.
- Mentor peers and coordinate statisticians across projects to deliver on time with high quality.
🎯 Requirements
- MS or PhD in Statistics, Biostatistics or related field; PhD with 2-4 years of experience or MS with 5-7 years of experience.
- Strong SAS skills.
- Respiratory & Immunology TA experience (Asthma Study).
- Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies (FDA).
- Excellent oral and written communications skills; ability to effectively communicate internally and with clients.
- Demonstrated understanding of statistics, drug development process and FDA regulations.
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