The 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.
Our companyThe work environment
At Indero, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities.
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
About Indero
Indero is a contract research organization (CRO) specialized in dermatology with a team of over 350 employees. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
We thank you for your application and please note that only those selected for an interview will be contacted.
Indero only accepts applicants with a work permit for Canada.
Skills Required
- Work permit for Canada
What We Do
As a CRO (Contract Research Organization) specialized in dermatology and rheumatology, we provide scientific guidance, accurate results and customer satisfaction. Our unique service offering combines specialized Contract Research Services, knowledge of dermatology sites in North America and Europe reach and the extended capabilities of a large clinical research site. The design and conduct of Phase I to Phase IV studies is our core expertise. Our specialized services include: • Study Design and Protocol Development • Submission to Regulatory Agencies and Central Ethics Committees • Regulatory Consulting • Trial Master Files Management • Project Management • Investigator / Site Selection • Patient Recruitment • Clinical Monitoring • Medical Monitoring • Pharmacovigilance • Data Management • Biostatistical Analysis • Clinical Study Report • Medical Writing / Publication Since 2000, Innovaderm has built a strong reputation for the quality of its research and the care offered to its study participants, its clients and its sites, often exceeding our client’s timeline expectations.
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