Senior Biostatistician

Job Title

Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

Job Description

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

Your primary responsibilities will include 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

Qualifications

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 I 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