Qualifications

• Ph.D. or MS in Statistics or Biostatistics required.
• 4+ years (Ph.D.) or 6+ years (MS) experience in the Pharmaceutical/CRO industry.
• Strong proficiency in SAS programming.
• Deep understanding of ICH guidelines and CDISC data standards.
• Strong organizational and time management skills for meeting deadlines.
• Excellent communication skills for effective teamwork and interfacing.
• Proven ability to work autonomously and solve problems.

Responsibilities

• Review and design clinical trial protocols, including statistical sections and sample size calculations.
• Oversee CRF and database design, including edit check specifications.
• Monitor study quality and oversee statistical activities throughout the study.
• Prepare and review statistical analysis plans (SAP), TFL shells, and variable specifications.
• Collaborate with Statistical Programmers and Clinical Data Managers to resolve data quality issues.
• Provide statistical support for analyses and interpretation of results drawing from datasets and TFL.
• Review and contribute to study reports, manuscripts, and regulatory documents.

Benefits

• Opportunity for professional growth in a leading pharmaceutical environment.
• Collaborative work with cross-functional teams and external vendors.
• Exposure to a variety of responsibilities within statistical and regulatory domains.
• Flexibility to work independently, with leadership opportunities for CRO teams.
• Engagement in meaningful work impacting drug development and regulatory success.