Senior Statistical Programmer utilizing R/RShiny to generate data analyses for life sciences applications. Collaborating with teams to ensure quality standards and regulatory compliance in statistical analysis.
Responsibilities
Uses R/RShiny 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
Transfers deliverables
Performs other work-related duties as assigned
Minimal travel may be required
Requirements
Advanced degree in Statistics, Computer Science, or a related field
Extensive experience in statistical programming in a clinical or pharmaceutical setting
Experience with CDISC programming (SDTM, ADaM)
Experience with clinical trials and biomarker analyses
Proficiency in the following programming languages: R and RShiny
Strong understanding of statistical methods and data analysis techniques
Excellent problem-solving and analytical skills
Ability to work independently and as part of a team
Strong communication and interpersonal skills
Certifications SAS Certified Advanced Programmer for SAS 9 or equivalent certification preferred
Benefits
We are passionate about developing our people, through career development and progression
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