Principal Statistical Scientist (Biostatistician)

Canada, Ontario, Mississauga

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Title: Principal Statistical Scientist (Biostatistician)

Department: Biostatistics

Location: Mississauga Head Office

This is a Director level position.

Objective:

The Principal Statistical Scientist (PSS) is responsible for providing statistics expertise and strategic drug development leadership for the most complex and high impact clinical development projects, development science applications, and/or product manufacturing applications.

The PSS accountabilities typically extend to representing all Biostatisticians, Real-World Data scientists, Outcomes Research scientists, Statistical Programmers, and Clinical Data Managers on highly complex and visible global development teams.  These accountabilities can extend to leading a global development team that includes clinical, safety and regulatory scientists.  The PSS typically supervises statisticians working within the project and may take on formal line management responsibilities. 

The PSS impacts the Biostatistics function and Therapeutic/nonclinical area beyond an individual project/application.  He/she mentors other statisticians, offers advice and expertise to benefit other clinical projects/nonclinical applications, leads high impact and broad initiatives, and partners with relevant managers to help determine and develop the technical/strategic capabilities needed to ensure functional excellence.

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, Outcomes Research scientists, statistical programmers, and clinical data managers on a Global Development Team.
  • Provides statistical leadership for clinical development projects, including providing strategic input into clinical development plans and target product profiles.
  • Takes responsibility 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.
  • Leads cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation
  • Company Biostatistics lead for Health Authority interactions
  • Serves as member of business development due diligence efforts
  • Influences development strategies that extend beyond a single project.  E.g., disease-area strategies, innovative trial designs or analysis.

2. Nonclinical Statistics

  • Provides statistical leadership to complex and/or high visibility nonclinical projects.
  • Identifies new opportunities for nonclinical biostatistics contributions and develops and implements solutions.
  • Directly responsible for the statistical integrity, adequacy, and accuracy of nonclinical studies.
  • Serves as expert statistical consultant for nonclinical projects within area of focus
  • Leads the education and appropriate empowerment of partners on statistical capabilities, including developing statistics courses.
  • Expert contributions to technical review forums and review of regulatory filing material

3. People Development and Management

  • Mentors statisticians
  • Typically supervises statisticians working within the project
  • May take on formal line management responsibilities

Qualifications:

  • Minimum Master’s Degree in statistics, biostatistics, mathematics or similar areas of academic discipline
  • 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
  • Excellent 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 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)
  • Proficient mentoring other statisticians.
  • Demonstrated ability to lead complex teams and projects with high impact

Qualified candidates are encouraged to submit a 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.