Toronto, Ontario – Biostatistician/SAS Programmer

Reports to: Principal Biostatistician, Pharmacometrics

Position Summary:

Biostatistician/SAS Programmer who will be responsible for the development of standard SAS Macros and programs in accordance with standard programming practices to design and develop Tables, Listings and Graphs as outlined in the Clinical Study Protocol and / or Data Analysis Plan. The qualified individual also is required to review the clinical study protocol and report, to assist in the development of the Data Analysis Plan, and development of SAS program of CDISC SDTM and ADaM according to dataset specifications

Duties and Responsibilities:

  • Develop and validate SAS codes for the analysis of clinical study data, generate output tables, listings and graphs in according with the study protocol and the data analysis plan (DAP)
  • Create randomization scheme for clinical research studies
  • Perform the statistical data analysis for clinical research studies utilizing the validated in- house SAS codes according to study protocol and departmental SOP
  • Review data quality and statistical outputs (QC process)
  • Review the clinical study protocol and report
  • Assist in the development of the Data Analysis Plan for required clinical research studies
  • Involve in the creation of CDISC SDTM and ADaM datasets
  • Implement data specifications to transform study data into CDISC-compliant datasets (SDTM and ADaM) in XPT format using SAS for electronic submission under the supervision
  • Participate in the development of SAS codes to execute the back-end edit checks
  • Work closely with team to implement protocol methodology and statistical plan to assure timely, accurate, complete and consistent analyses for clinical data
  • Perform other miscellaneous activities as required

Qualifications:

  • Sc in Statistics or Biostatistics, experience with SAS/Base, SAS/Macro, SAS/SQL and SAS/Graph
  • Experience with SAS/Stat is required
  • At least 1-2 years of Biostatistical consulting and/or SAS programming experience in the pharmaceutical industry or in the field of clinical research is required
  • Proficiency with Microsoft Office
  • Knowledge of clinical drug development process and knowledge of FDA and other regulatory requirements and ICH/GCP guidelines
  • Knowledge of Clinical Data Interchange Standards Consortium (CDISC) guidelines
  • Good interpersonal skills, good communication skills
  • Attentive to details, good initiative and able to work with changing priorities

Please send your resume to resumes@biopharmaservices.com