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Fwd: [d-ssc] Job Opportunity: Associate Statistical Scientist (Biostatistician Level 2)




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: Associate Statistical Scientist (Biostatistician Level 2)
Date: February 29, 2016 at 8:04:27 AM PST

Roche Canada
Title: Associate Statistical Scientist (Biostatistician Level 2) 
Department: Biostatistics 
Location: Mississauga Head Office

Multiple Positions Available

Objective: 

The Associate Statistical Scientist partners with senior scientists in biostatistics, 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 strategies to address drug development needs and designing experiments, and evaluating and preparing study results for health authorities and the medical/research community. Within Clinical Development, this also entails effective collaboration with Operations, Data Management, and Statistical Programming personnel. 

Responsibilities: 

1. Clinical Development

  • A member of cross-functional Study Management Teams
  • Study Planning: With assistance of senior statistical scientists, reviews study protocols, authors statistical sections of protocols
  • With assistance of senior statistical scientists develops independent data monitoring and endpoint committee charters.
  • 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 statistical programming, ensuring the accuracy and validity of results.
  • Analysis & Reporting: Author 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.

2. Nonclinical Statistics

  • Study Planning: With assistance from senior staff, provides experimental design and analysis strategies to nonclinical projects in Research, Preclinical Development Science, Bioprocess Development and Manufacturing.
  • Analysis and Reporting: With assistance from senior staff, 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: With assistance from senior staff, 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. 
Show less
If you are interested, please click on the link to apply: Associate 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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