This position functions as a member of the Biostatistics and Statistical Programming project team serving as a Lead Statistical Programmer for projects of any complexity in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project; assists in managing project budgets and tracking project specific performance metrics; functions as an internal and external customer liaison; provides input to the statistical analysis plan; leads the creation and maintenance of statistical programming project documentation.
Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
Works to ensure that outputs meet quality standards and project requirements.
Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
Keeps project team members informed of programming progress and issues requiring their attention.
Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.
Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted.
Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
Performs other work-related duties as assigned.
Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.
Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
Excellent written and verbal communication skills.
Ability to read, write, speak and understand English.
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.
Since you are applying from outside Canada, you application will be moderated by our team. You will receive an email once it's been approved.
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You must be legally entitled to work in Canada in order for your application to be considered.
I am legally entitled to work in Canada
Application from outside Canada
Finding an employer that will assist you in your work permit without knowing you is utopic.. Employers simply do not consider non-resident applications. We strongly recommend that you immigrate to Canada before you start looking for employment.