Associate Director Biostatistician – Medical Affairs

Overview

• Lead statistical activities supporting Medical Affairs, including post-approval evidence generation, study design, and exploratory analyses.
• Collaborate with cross-functional teams to develop protocols and statistical analysis plans for observational and clinical studies.
• Provide statistical guidance on ongoing studies and contribute to regulatory document preparation.
• Implement statistical analyses for clinical trial, registry, and non-interventional data supporting Medical Affairs objectives.
• Contribute to scientific articles, abstracts, and manuscripts summarizing study data.
• Support data management activities, including eCRF design and data analysis coordination.
• Participate in meetings and activities to enhance Biostatistics and Medical Affairs team collaboration.

Key Responsibilities & Duties

• Lead statistical support for post-approval evidence generation and reimbursement submissions.
• Conduct post-hoc analyses for publications and presentations.
• Develop statistical sections for study protocols and analysis plans.
• Collaborate with Statistical Programming to implement analyses for Medical Affairs data.
• Provide guidance on observational studies and ongoing clinical studies.
• Contribute to regulatory documents and observational study reports.
• Support cross-functional teams in study design and data analysis coordination.

Job Requirements

• PhD in Biostatistics, Statistics, or equivalent; MS with significant relevant experience considered.
• Extensive experience in SAS programming and clinical study data analysis.
• Proficiency in R programming and familiarity with CDISC standards.
• Understanding of ICH GCP and industry practices.
• Strong communication and presentation skills.
• Experience with post-approval observational and clinical studies.
• Ability to collaborate effectively with cross-functional teams.