Senior Biostatistician

What You'll Do

The primary responsibilities of this position include, but are not limited to, the following:

• Ensures successful completion of high-quality statistical deliverables
• Writes and/or reviews statistical sections of protocols
• Assists in protocol study design (determines sample sizes for all phases of trials)
• Writes Statistical Analysis Plans (SAPs)
• Writes Tables, Listings and Figures Plans (TLF Plans)
• Reviews and/or designs Case Report Forms (CRFs)
• Reviews and/or writes randomization and blinding plans
• Reviews and/or writes charters for Data Monitoring Committees (DMCs)
• Provides SAS code for statistical models
• Validates/performs SAS programming for key data analyses
• Performs quality control on derived variables being analyzed
• Interprets results from analysis
• Maintains documentation
• Reviews Clinical Study Reports (CSR)
• Keeps abreast of statistical literature/design

 

What You Need

Level of Education

Master’s degree in Biostatistics or equivalent, required

 

Prior Experience

5+ years of experience in clinical biostatistics, required  

Prior experience in a CRO/pharmaceutical environment, required

Oncology clinical trials preferred

Experience with phase 1 trials preferred

 

Skills and Competencies

• Expertise in statistical concepts and design
• Understands the investigational drug development process
• Demonstrates ability to build and maintain effective relationships with others
• Strong communication, organizational and decision-making skills
• High level of agility and diplomacy
• Must be able to anticipate challenges and project risks and proactively implement solutions
• Strong time management and effective planning skills
• Knowledge of Standard Operating Procedures
• Working knowledge of FDA and ICH guidelines
• Working knowledge of MS Office and Outlook