Statistical Scientist (Biostatistician 3) - Pharma Development

Employer

Statistical Scientist (Biostatistician 3) - Pharma Development
Canada, Ontario, Mississauga

Job facts

Title: Statistical Scientist (Biostatistician Level 3)
Division: Pharma Development-Biostatistics
Location: Mississauga Head Office

Multiple Positions Available!

Objective:

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.

Responsibilities:

Clinical Development

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

Functional Area

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.

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Qualifications:

Minimum MSc in statistics, biostatistics, mathematics or similar areas of academic discipline; PhD is preferred.
Experience using statistical software.
Good knowledge of theoretical and applied statistics
Very good knowledge and more than 2 years experience applying statistical methods to drug development
Good understanding of regulatory guidelines in a pharmaceutical research setting

The successful incumbent must be legally permitted to travel to the United States for business purposes

Qualified candidates are encouraged to submit cover letter asap. This position will be posted until filled.

Key words: Biostatistician, Statistician, clinical trials, statistics

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.

Who we are

Roche Pharma - Canada has its office in Mississauga, Ontario and employs over 700 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.