Senior/Principal Statistical Programmer

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

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