Perform duties of a Biostatistician to support clinical trials. Assure well-designed clinical trials. Provide statistical expertise necessary to support the design as well as analyze, interpret and communicate the results of clinical trials.
Duties & Responsibilities:
- Perform duties of a Trial Statistician to support regular clinical trials within national or international development projects as required. Collaborate with Trial Clinical Monitor and trial teams in planning clinical protocols conforming to company and regulatory agency guidelines.
- Support statistical Methodology sections for the protocols and the Statistical Analysis Plans (SAPs) and author the TFL shells.
- Analyze data from phase I to III trials incl. TFL shell development and responsibility for program validation.
- Review and evaluate proposed case report forms for consistency with information needs for the protocol.
- Review randomization to be used in the clinical trials.
- PhD or equivalent experience in statistics, biostatistics, or biometry experienced in designing, conducting, analyzing and/or presenting routine trials/studies working with a team to apply statistical methodology to a research question
- Experienced in SAS/R programming.
- Good oral and written communication skills.
- Attention to Detail - Possess a strong quality orientation. Ensure tasks are completed correctly and on time.
- Thorough knowledge of statistical methodology, design of clinical trials and on processing clinical trial information