Senior/Principal Biostatistician

The senior/principal biostatisticians will be supporting Phase 2 or 3 studies and be hands-on with data checking, programming, and statistical analysis deliverables under guidance.

• Master's in Statistics, Biostatistics, or related field with 5+ years of experience in the design, analysis, and reporting of clinical studies.
• OR
• PhD in a related field with 3+ years of experience
• Demonstrated experience in SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data.
• Significant experience working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets.
• Support Phase 2 and Phase 3 clinical studies through statistical analysis and reporting activities.
• Perform clinical study data checking, review, and quality assessments.
• Develop and maintain SAS programs for statistical analyses of clinical trial data.
• Perform statistical analyses using appropriate SAS procedures and methodologies.
• Support the design, analysis, and reporting of clinical studies.
• Prepare and review statistical analysis deliverables under appropriate guidance.
• Work with clinical datasets to identify data issues, inconsistencies, and trends.
• Support the specification and creation of SDTM and ADaM datasets.
• Ensure datasets and statistical programming activities align with CDISC standards.
• Apply relevant FDA standards and regulatory requirements to clinical data deliverables.
• Collaborate with biostatistics, statistical programming, clinical data management, and other cross-functional teams.
• Contribute to the preparation and review of clinical study reports and statistical outputs.
• Support data and programming activities required for clinical development and regulatory submissions