Associate Director, Biostatistics

Who We Are

Celebrating 40+ Years!

 

Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to ensure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease. 

What You'll Do

Associate Director, Biostatistics  - Home Based - Oncology Clinical Trials

 

Our company’s reputation is built upon assuring scientific objectivity and high-quality study conduct to fulfill all regulatory requirements. At Theradex, you will work in an environment that encourages both individual contribution and collaborative entrepreneurial thinking. 

 

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

 

• Manages priorities and timelines for statistical deliverables
• 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)
• Reviews/authors Standard Operating Procedures (SOPs) related to biostatistics
• Keeps abreast of statistical literature/design
• Oversees the statistics and programming work for Data Monitoring Committee Program (~ 15 Phase II/III Oncology trials) 

 

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

 

Skills and Competencies

• Expertise in statistical concepts and design
• Understands the investigational drug development process
• Demonstrates strong strategic and critical thinking skills
• Demonstrates ability to build and maintain effective relationships with others
• Results-oriented; effective ability to set and meet short-term and long-term goals
• Strong communication, organization 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

 

Additional Requirements

•  May require occasional travel for BID defenses, audits, and/or sponsor visits

 

What We Offer

 

We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, short term/long term disability (STD/LTD), company matched 401(k), competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.   

 

 

Theradex is an Equal Opportunity Employer. 

Relocation assistance or company provided sponsorship is not offered for this position. 

 

No agencies please.