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

#J-18808-Ljbffr