The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients. Responsibilities include collaborating with multi-disciplinary project teams to establish project objectives and timelines; writing statistical sections of clinical trial protocols; authoring statistical analysis plans; monitoring internal and CRO project activities; collaborating with Data Management, Clinical Development, and Clinical Operations; contributing to clinical study reports and regulatory documents; providing guidance and supervision to programmers; performing validation of analysis variables and statistical outputs; interpreting study results; supporting exploratory analyses; participating in pre-IND or NDA activities; and supporting Biostatistics and the Development Team as needed. Qualifications include a PhD in Statistics, Biostatistics, or related field with 5+ years industry experience or MS with 7+ years, at least 3 years in Phase 2/3 clinical trial experience, ability to work independently, effective communication skills, proficiency in R or SAS, understanding of ICH GCP and industry standards, and experience with CDISC standards. Desired experience includes multiple imputation methods. The role offers home-based remote working opportunities, flexible schedules, technical training, research opportunities, and a promising career trajectory.
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