Senior Biostatistician

Job Summary

A company is looking for a Senior Biostatistician FSP for Late Phase drug development programs.

Key Responsibilities

• Collaborate with multidisciplinary project teams to establish project timelines and provide statistical input to study protocols
• Write or review statistical analysis plans and manage internal and CRO project activities
• Perform inferential analyses using SAS and/or R, and contribute to clinical study reports and regulatory documents

Required Qualifications

• PhD in Statistics, Biostatistics, or related field with 3+ years of industry experience, or MS with 5+ years of experience
• Understanding of ICH and FDA Guidance, along with knowledge of industry practices and standards
• Experience with CDISC, including SDTM, ADaM, and CDASH
• Familiarity with R programming language and statistical software
• Experience in regulatory submission activities and knowledge of estimand framework