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Fwd: [d-ssc] Job Opportunity: Statistical Scientist (Biostatistician Level 3)




Richard Lockhart, Professor

Stat & Act Sci; Simon Fraser Univ.     
Phone:  (778) 782-3264
Burnaby BC V5A 1S6                     FAX:    (778) 782-4368
e-mail:   lockhart@sfu.ca





Begin forwarded message:

From: "Mangra, Chitra" <chitra.mangra@roche.com>
Subject: [d-ssc] Job Opportunity: Statistical Scientist (Biostatistician Level 3)
Date: February 29, 2016 at 8:06:36 AM PST

Roche Canada
Title: Statistical Scientist (Biostatistician Level 3) 
Department: 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: 

1. 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
  • Participates in health authority meetings

2. Nonclinical Development

  • Study Planning: Provides experimental design and analysis strategies to nonclinical projects.
  • Analysis and Reporting: Performs statistical analyses for nonclinical studies, provides input to IND and BLA submissions and to regulatory response to global health authority investigations related to marketed products, and contributes to publications and presentations.
  • Statistical Consulting: Provides statistical advice to nonclinical investigators and contributes to the development of statistics courses.

3. 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.

4. People Development

  • Mentor other statisticians on request
Show less
If you are interested in applying, please click on the link to apply: Statistical Scientist

Warmest Regards,

Chitra Mangra
Talent Acquisition Manager
Hoffmann-La Roche Limited 
7070 Mississauga Road 
Mississauga, Ontario L5N 5M8 
Bus: 905-542-5555 ext. 4549 
Cell: 647-203-3855

Fax: 905-542-5525

E-mail: chitra.mangra@roche.com

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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.

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