Biostatistician II

Parexel • Newton, MA

12d • Hybrid

About The Position

Parexel International LLC seeks a Biostatistician II to conduct statistical analysis on clinical trials according to industry standards and government regulations under limited supervision. This role involves completing clinical trial statistical analysis projects within timeline and budget in coordination with cross-functional project teams. The Biostatistician II will perform quality control of derived datasets, tables, figures, and data listings produced by other members of the department, and understand and apply advanced statistical methods. This position is responsible for defining randomization specifications and writing statistical sections of protocols, analysis plans, statistical reports, statistical sections of integrated clinical reports, and other process-supporting documents. The role also involves liaising with clients as a key contact regarding statistical and contractual issues, providing training in statistical analysis to internal clients, and conducting the production and quality control of derived datasets and both simple and advanced statistical outputs using efficient programming techniques. The Biostatistician II will attend and actively contribute to client meetings, including discussing and presenting analysis concepts and study results. Telecommuting is permitted from anywhere in the US up to 5 days per week.

Requirements

• Master’s degree in Biostatistics or a related field
• 6 months of statistical analysis experience
• 6 months of experience in Programming in SAS, R, Python, and MATLAB
• 6 months of experience in Leading projects in biomedical research, including leading the development and execution of statistical analysis plans in multiple therapeutic areas
• 6 months of experience in Analysis and statistical modelling utilizing ANCOVA, logistic regression, survival analysis, and MMRM
• 6 months of experience in Statistical analysis in early- and late-phase clinical trials and drug development
• 6 months of experience in Creating table, listing, and figure shells
• 6 months of FDA/CDISC experience
• 6 months of experience in Reviewing SDTM and ADaM datasets, and table, listing, and figure outputs

Responsibilities

• Conduct statistical analysis on clinical trials according to industry standards and government regulations under limited supervision.
• Complete clinical trial statistical analysis projects within timeline and budget in coordination with cross-functional project teams.
• Perform QC of derived datasets, tables, figures, and data listings produced by other members of the department.
• Understand and apply advanced statistical methods.
• Define the randomization specifications and write statistical sections of protocols, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents.
• Liaise with clients as key contact with regard to statistical and contractual issues.
• Provide training in statistical analysis to internal clients.
• Conduct the production and QC of derived datasets and both simple and advanced statistical outputs using efficient programming techniques.
• Attend and actively contribute to client meetings as appropriate, including discussing and presenting analysis concepts and study results.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level