About the role
Who We Are
Celebrating 40+ years!
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.
What You'll Do
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.
Opportunity
We are hiring a Sr Biostatisician in the UK
Key Responsibilities
- 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 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 Offer
- We offer a friendly and supportive culture that puts people first. We provide a competitive compensation and benefits package including 6% pension contribution, private medical insurance, sick pay and income protection insurance, life assurance, eyecare voucher scheme and employee assistance program.
- Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.
- This job does not offer company sponsorship.