Title: Statistical Scientist (Biostatistician Level 3)
Divisions Hiring: Pharma Development-Biostatistics and US Medical Affairs
Location: All positions located at Mississauga, ON Head Office (Canada)
Multiple Positions Available!
The Statistical Scientist partners with senior scientists in clinical, safety, epidemiology, regulatory, research, and manufacturing on clinical development projects, research applications, development science applications, and/or product manufacturing applications. This typically includes partnering with senior scientists in the creation of clinical development plans and non-clinical strategies, and having primary strategic and operational responsibility for the design, conduct, and evaluation of experiments. For clinical development programs, the Statistical Scientist typically is the lead Biostatistics representative on cross-development global clinical study teams.
- Member of clinical team, collaborating in preparation of Clinical Development Plans and target product profiles; typically lead statistician on cross-functional study management teams or sole statistician on early development project teams
- Study Planning: Reviews study protocols, authors statistical sections of protocols, prepares the study randomization, develops the statistical and data analysis plans, develops independent data monitoring and endpoint committee charters.
- Study Conduct: Reviews case report forms to ensure protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, review and approve analyses produced by statistical programming
- Analysis & Reporting: Authors the clinical study report, provides input into global health authority documents and regulatory response for health authority submissions. Contributes to study publications and presentations. Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling.
- Oversees the deliverables from Statistical CROs
- Leads cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation and participates in health authority meetings
- Understand and apply business requirements and processes. Participates in functional training.
- Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc.
- Participates in Biostatistics and cross-functional initiatives. Participates in the development of functional processes
- Recognized expertise in clinical trials and statistical methodology for a clinical indication and/or statistical methodology for specialized applications.