Title: Statistical Scientist (Biostatistician)- 2 Year Contract
Location: Mississauga Head Office
Multiple Positions Available!
The Statistical Scientist partners with senior scientists in biostatistics, clinical, safety, epidemiology, regulatory, research, and manufacturing on clinical development projects, research applications, development science applications. This typically includes partnering with senior scientists to support drug development needs, and evaluating and preparing study results for health authorities and the medical/research community. Within Clinical Development, this also entails effective collaboration with statisticians, Operations, Data Management, and Statistical Programming personnel.
- A member of cross-functional Study Management Teams
- Provides support to across various therapeutic areas to senior statistical scientists
- Study Planning: With assistance of senior statistical scientists, reviews study protocols
- With assistance of senior statistical scientists develops independent data monitoring and endpoint committee charters.
- With assistance of senior statistical scientists develops the statistical and data analysis plans, and prepares the study randomization
- 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 senior statistical scientists, statistical programming, ensuring the accuracy and validity of results.
- Analysis & Reporting: Assist in authoring the clinical study report, and with assistance of senior scientists and cross-functional team members provides input into global health authority documents and regulatory response for health authority submissions
- Contributes to study publications and presentations, and provides analytical support for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling.
- Understand and apply business requirements and processes. Participates in functional training.
Minimum MSc in statistics, biostatistics, mathematics or similar areas of academic discipline + 2 years of experience in:
- Experience using statistical software.
- Solid knowledge of theoretical and applied statistics
- Developing knowledge and experience applying statistical methods to drug development
- Developing understanding of regulatory guidelines in a pharmaceutical research setting
- Good Communication and Collaboration Skills (including statistical consulting skills, interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative relationships with scientific and non-scientific partners)
- Project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors)
- Understands and applies Business requirements and processes
- Understands and respects cultural differences when interacting with colleagues in the global work place
- Accomplishes responsibilities with supervision
- Good knowledge of English in a business environment.
Qualified candidates are encouraged to submit cover letter and resume asap. This posting will remain up until all positions are filled.
This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in Canada.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process
AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.