Number of Openings: 1
Travel: Yes, International
Remuneration: Attractive Package + Share Options
Tumour Trace seeks qualified candidates to serve as Biostatisticians in support of the Device and Statistical Learning Algorithms, and Clinical Studies teams. Successful candidates will have a strong background in statistics, including advanced statistical methodologies such as statistical learning and the ability to use these methodologies to classify diagnostic datasets.
Successful candidates must have superior communications skills, and demonstrate the ability to convey sophisticated concepts to senior Tumour Trace leadership.
Potential to lead a study with slight to moderate support and oversight, with working knowledge of CE and FDA regulations and general industry standards.
- Support team members by cleaning data, creating exploratory tables and listings, reviewing output, and validating analyses
- Assist with sample size and power and classification calculations
- Assist in developing Statistical Analysis Plan and create table, listing, and figure shells
- Able to code statistical analyses and familiar with good coding practices
- Provide biostatistics support for Clinical Study team
- Assist in interpretation and writing of results
- Support preparations for interactions with regulatory agencies
- Read and understand Medical/Clinical literature as required by duties
- Assist in maintenance of department tools, templates, guidelines, SOPs, and systems.
- Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Develop knowledge of CE and FDA regulations.
- MSc or PhD in Statistics, Biostatistics, Epidemiology or related field
- Knowledge and experience using statistical programming software
- 2+ years of experience
- Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required
- Working knowledge of CE and FDA regulations
- Able to prioritize work and complete deliverables to timelines
- Excellent verbal and written communication skills
- Detail and process oriented