Job Description - Lead Biostatistician - Canada (19004404)
Lead Biostatistician - Canada-(19004404)
the lead or back-up statistician for multiple projects with any level of
complexity.Acts as the primary contact
with the sponsor for all biostatistics related activities on assigned
projects.Helps manage clinical trials
efficiently by providing accurate and consistent information to both sponsors
and Company business/functional units.
in the process of protocol development by choosing an appropriate study design,
including statistical methodologies, calculating necessary sample size to
achieve a pre-specified power, and writing the statistical section of the
protocol.Sample size calculations may
require some literature search to ensure that the study assumptions are
and reviews Statistical Analysis Plans (SAPs) based on the protocol, including
development of well-presented mock-up displays for tables, listings, and
figures.Collaborates with sponsor.
the activities of other Biostatistics personnel on assigned projects to ensure
timely completion of high quality work.Provides independent review of project work produced by other
statisticians in the department.
in project teams as Biostatistics representative, interfacing as necessary with
other departmental project team representatives.
business development activities by contributing to proposals, budgets, and
attending sponsor bid defense meetings.
or reviews programming specifications for analysis datasets, tables, listings,
in Data Safety Monitoring Board and/or Data Monitoring Committee activities,
including charter development and serving as an independent non-voting
and participates in review and quality control of project deliverables,
ensuring that output meets expectations and is consistent with analysis
described in SAP.
time estimates for completion of study related activities with the Lead Statistician
or Biostatistics management and proactively communicate to the Lead
Statistician or Biostatistics management any difficulties with meeting these
timelines.Monitors progress on study
activities against agreed upon milestones and
ensures the study timelines for project deliverables are met.Identifies out of scope tasks and escalates
proper study closeout by documenting and archiving study related materials
according to Standard Operating Procedures (SOPs), and/or sponsor instructions.
and/or reviews randomization schedule(s) to ensure there are no errors present
and sponsor and protocol requirements are met.Performs ongoing monitoring of actual randomization scheme applied by
willingness to work with others and assist with projects and business unit
initiatives as necessary to meet the needs of the business.
Performs other work-related
duties as assigned.Minimal travel may
be required (up to 25%).
Note:If there are additional responsibilities that are specific to an
individual employee, department, country, or other grouping, please use the Job
Description Addendum Template.
MS or PhD in
Biostatistics or related field.Moderate
experience in clinical trials or equivalent combination of education and
experience.Experience in SAS
programming.Excellent knowledge of
statistical theory including experimental design, categorical data analysis,
analysis of variance (covariance), survival analysis, and non-parametric
methods.Effective written and verbal
communication skills.Ability to apply
knowledge of basic statistical design, analysis, ICH guidelines, and
programming techniques utilized in clinical research and to effectively
communicate statistical concepts.Ability to read, write, speak, and understand English.
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