DescriptionThe Senior Statistical Advisor will provide statistical input into Phase I - IV clinical trial development, assist in protocol development, customer relationships, support statistical requirements for submissions, support data analysis and interpretation and support research and development. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Innovaderm's commitment to sponsor's requirements and timelines.
RequirementsMore specifically, the Senior Statistical Advisor must:
- Provide statistical input into protocols (e.g., trial design, sample size estimation, power calculations, randomization, statistical methods for protocols).
- Communicate with clients regarding study protocol or statistical analysis issues.
- Review statistical analysis plans.
- Review clinical trial data results representing the outcome of the trial, validating statistical output, accurately interpreting, and clearly communicating statistical results and concept to non-statisticians.
- Provide support to scientific writers working on Clinical Study Reports.
- Advise on the design of valid, efficient, and cost-effective clinical trials and other research projects.
- Provide input into statistical standard operating procedures (SOPs) and general standardization efforts (e.g., statistical methodology standards, standard data presentations).
- Collaborate effectively with members of clinical trial implementation teams, and keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they havE the required experience, are qualified and/or have received adequate training.
As a Senior Statistical Advisor, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
- Ongoing learning and development
