What You'll DoAs 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
What You NeedLevel 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
What We OfferAt Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $130,000-$160,000. The actual salary offer will be based on a number of factors, including but not limited to the candidate's qualifications, experience, skills, and competencies for the role.
This position is not eligible for relocation or company provided sponsorship.
