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





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From: "Mangra, Chitra" <chitra.mangra@roche.com>
Subject: [d-ssc] Job Opportunity: Senior Statistical Scientist (Biostatistician- Director Level)
Date: March 19, 2018 at 9:44:51 AM PDT

Roche Canada
Title: Senior Statistical Scientist (Biostatistician) 
Department: Biostatistics 
Location: Mississauga Head Office 

Director Level Position

Objective:

The Senior Statistical Scientist is responsible for providing statistics expertise and strategic drug development leadership for clinical development projects, research applications, development science applications, and/or product manufacturing applications, and is directly accountable for the statistical integrity, adequacy, and accuracy within these endeavours. The Senior Statistical Scientist accountabilities typically extend to representing all Biostatisticians, Real-World Data Scientists, Patient-Centered Outcomes Research Scientists, statistical programmers, and clinical data managers on global development teams. 

Responsibilities: 
1. Clinical Development

  • Operates at the Global Development Team level, either as Project Lead Statistician or as the sole representative for Biostatisticians, Real-World Data Scientists, Patient-Centered Outcomes Research Scientists, statistical programmers, and clinical data managers on a Global Development Team.
  • Provide statistical leadership for clinical development projects, including providing strategic input into clinical development plans and target product profiles.
  • Directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies within the project, including activities to support personal healthcare strategy and governance committee decision making
  • Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling.
  • May serve as lead statistician for one or more study management teams, with the incumbent responsibilities and accountabilities.
  • Leads cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation
  • Company Biostatistics lead for Health Authority interactions
  • Oversees the deliverables from Statistical CROs.
  • Serve as member of business development due diligence efforts.

2. Nonclinical Statistics

  • Provides statistical leadership to nonclinical projects.
  • Directly responsible for the statistical integrity, adequacy, and accuracy of nonclinical studies.
  • Serves as expert statistical consultant for nonclinical projects and drives the development of new statistics courses.
  • Establishes new technical directions and collaborations within assigned area of focus.

3. Functional Area

  • Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc.
  • Leads Biostatistics and cross-functional initiatives
  • Leads 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 statisticians on request

Qualifications:
  • Minimum Master’s Degree Specify: MSc in statistics, biostatistics, mathematics or similar areas of academic discipline
  • Experience using statistical software.
  • Very good knowledge of theoretical and applied statistics
  • Excellent knowledge and experience applying statistical methods to drug development
  • Very good understanding of regulatory guidelines in a pharmaceutical research setting
  • Proficient 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)
  • Excellent Project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors)
  • Proficient Strategic Agility (including problem-solving and critical thinking skills, ability to drive drug development strategies, agility that extends beyond statistical aspects)
  • Excellent Drive for Results (Demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges; finds solutions to technical problems)
  • Effective mentoring other statisticians.
  • Good knowledge of English in a business environment.
  • Understands and applies Business requirements and processes
  • Understands and respects cultural differences when interacting with colleagues in the global work place
  • Accomplishes responsibilities with little supervision

Qualified candidates are encouraged to submit cover letter and resume asap.  This posting will remain opened until 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.



Chitra Mangra
Talent Acquisition Manager
Hoffmann-La Roche Limited 
7070 Mississauga Road 
Mississauga, Ontario L5N 5M8 
Bus: 905-542-5555 ext. 34549 
Cell: 647-203-3855

Fax: 905-542-5525

E-mail: chitra.mangra@roche.com

Candidate and Hiring Manager Alert: Please note that our Roche Applicant Tracking System, Taleo, will be inaccessible starting April 20 until April 25. Please be ready to manage your application or any open requisition with those dates in mind.

Upcoming Absences:



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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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