Biostatistician
RemoteUnited States
Job Summary
Design statistically sound clinical trials by collaborating with clinical and regulatory teams on sample size calculations and randomization methods. Develop and review statistical analysis plans in compliance with regulatory guidelines, then perform analyses using SAS, R, or other statistical software on clinical trial datasets. Interpret results to present findings in clinical study reports, regulatory submissions, and scientific publications while ensuring deliverables meet FDA, EMA, and ICH standards. Review case report forms and data validation rules for accuracy, resolving discrepancies with Data Management and Clinical Operations to maintain data integrity. Stay current on industry best practices, methodologies, and relevant regulatory guidance.
Required Qualifications
- Master's or Ph.D. in Biostatistics, Statistics, Mathematics, or a related quantitative field
- Minimum of 3 years (for MS) or 1 year (for PhD) of relevant experience in the pharmaceutical, biotechnology, or CRO industry
- Proficient in statistical programming languages such as SAS and/or R
- In-depth knowledge of ICH-GCP, CDISC standards (SDTM, ADaM), and regulatory guidance documents
- Strong understanding of clinical trial design, methodology, and regulatory requirements
- Excellent communication skills with the ability to interpret and present statistical findings clearly
- Strong attention to detail and a commitment to data quality and accuracy
- Authorization to work in the U.S. (E-Verify participation)
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