Integration Developer building Apache Camel, Kafka, and OpenShift solutions for PLATO, Canada’s Indigenous - owned software testing and technology services company. Delivering secure enterprise integrations, APIs, and automated data exchange.
About the role
- 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
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Commitment to building an inclusive culture
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