Job Title: Principal Biostatistician

Job Description

The Principal Biostatistician/Statistical Programmer will provide statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed products. The individual will ensure the application of appropriate statistical methods and generate accurate and reproducible results through error-free statistical programming in SAS, R, and/or other programming languages. This role involves close collaboration with the Director of Biostatistics, team members, and CROs to execute statistical and data needs.

Hard Skills

• Advanced SAS programming
• Proficiency in CDISC standards (SDTM & ADaM)
• Creation and review of submission documents and eCRFs
• Development of statistical analysis plans
• Generation and validation of SDTM and ADaM datasets
• Programming specifications and analysis datasets
• Support for creation and validation of submission requirements

Soft Skills

• Effective communication with cross-functional teams and clients
• Ability to juggle multiple projects simultaneously
• Proactive risk identification and mitigation
• Collaboration within multidisciplinary study teams

Job Type

This is a permanent position.

Work Site

This is a fully on-site position in Malvern, Pennsylvania.

Work Environment

This is an in-office position requiring employees to work in the office 5 days per week. The team is split between India and the US, with 4 members in India focusing on programming, data management, and statistics, and additional programmers and clinical data managers in the US. The Principal Biostatistician will report to the Director of Biometrics.