Position Title: Senior/Principal Statistical Programmer
Location: Head Office (Toronto, ON)
Status: Full-Time
Summary:
The Principal Statistical Programmer provides high quality programming solutions to support clinical studies in various therapeutic areas. She/he will work closely within a team of SAS programmers and Biostatisticians to support and perform analysis of clinical data.
We are looking for someone who has:
- BA or BSc Degree in Statistics, Math or Computer Science
- Minimum of 4 years’ experience in clinical programming using SAS
- Lead experience overseeing other programmers and projects
- Hands-on experience with CDISC, SDTM and ADaM standards
- CRO experience preferred
- Knowledge of Pinnacle 21
- Strong organizational skills
- High degree of accuracy with timelines and ability to meet deadlines
- Strong verbal and written communication skills
- Strong leadership skills
- Ability to multitask in a fast-paced environment
What you will be doing:
- Act as the Lead Programmer
- Responsible for SDTM package:
- Author/review/update SDTM specifications
- Program/review SDTM datasets
- Validate SDTM datasets
- Author SDTM reviewer’s guide
- Assess impact of protocol amendments to SDTM deliverables
- In collaboration with Senior/Principal Biostatistician:
- Update ADaM specifications
- Review and QC ADaM datasets programmed by junior staff
- Review and QC TLFs programmed by junior staff
- Program tables, listings and figures as per SAP for clinical research studies
- Import data from 3rd party clients (e.g. central lab transfers)
- Prepare data exports to be sent to clients
- Perform data checks (quality control) as needed to ensure integrity and accuracy of data displays
- Develop, test, document and maintain a library of SAS statistical macros
- Support CDM group in validation of clinical data
- Undertake project management activities as needed, including managing project team of statistical programmers, ensuring timely completion of deliverables with high quality
Position Title: Principal Clinical Data Associate
Location: Head Office (Toronto, ON)
Status: Full-Time
Summary:
The Principal Clinical Data Associate will manage CDM projects and resources to ensure quality, accuracy and consistency of clinical data.
We are looking for someone who has:
- BSc. in Life Sciences preferred, or Bachelor's degree with equivalent knowledge/experience
- Minimum 8 years of experience in clinical data management
- Experienced in managing CDM projects from design to database lock
- Experience with EDC systems, including Medidata Rave
- Knowledge and understanding of database build, testing and documentation
- Knowledge of Lotus Notes, an asset
- Experience in coding AEs, medical history and concomitant medications with MedDRA and WHODrug Global
- Knowledge of SAS, an asset
- Excellent communication and interpersonal skills
- Ability to work under minimum supervision
- Flexibility in prioritization changes
What you will be doing:
- Manage the CDM segment of studies: interface with Sponsor and 3rd party vendors, manage project CDM resources, ensure timely completion and quality of CDM deliverables.
- Gather database design and configuration specifications from the Sponsor
- Review DB designs to ensure consistency with protocol requirements
- Review custom data validation rules and checks for completeness and logic
- Performs UAT testing of database design and design updates, ensures all test documentation is complete prior to DB release
- Author and update CDM control documents, including Data Management Plan, SAE reconciliation, Laboratory / PK reconciliation plans, etc.
- Assess impact of protocol amendments on database design and recommend DB changes
- Performs clinical study data review (non-medical reviews)
- Reviews consistency of AE, medical history and medication coding
- Ensures all processes are completed for interim and final DB locks and performs final QC checks
- Provides CDM status updates to internal Project Manager and Sponsor
- Manage data transfers from 3rd party vendors and to Sponsor or 3rd party vendors
- Attends Sponsor team meetings
- Liaises with the Biostatistics group
- Participates in internal/external audits
- Oversees the work of other CDAs as required. This may involve on-the-job training, and ensuring the quality of work performed.
- Trains and mentors junior data management staff providing timely feedback to trainees and management as appropriate
- Other duties, as assigned.
Job Features
| Job Category | Full-Time |