What are the responsibilities and job description for the Senior Biostatistician position at Theradex Oncology?
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
