POSITION TITLE: Statistician/Senior SAS Programmer
DEPARTMENT: NCIC – Clinical Trials Group, Queen's University
The NCIC Clinical Trials Group (NCIC CTG) is a clinical trials cooperative group that conducts
prospective clinical trials research that is national and international in scope. The Group is
based at Queen’s University and includes faculty members and more that 100 staff. The Group’s
membership includes more than 1000 clinical investigators who are based in more than 90
Canadian academic and cancer treatment institutions. The Group conducts clinical trials that are
international in scope by collaborating with other international cooperative groups in both
leadership and supporting roles.
As part of the NCIC CTG’s Statistics and Information Technology Group, the Statistician/Senior
SAS Programmer holds an important role within the portfolio and reports directly to the
Information Technology Director of the NCIC CTG. The Biostatistician/Senior SAS Programmer
takes leadership role as a high-level SAS programmer to ensure statistical analysis plans and
validation programs using SAS are carried out and completed in a consistent, efficient manner,
are of high quality and in compliance with regulations, Group Standard Operating Procedures
(SOPs). This position assists Senior Biostatisticians, Physician Coordinators, Study Coordinators
and other clinical trial team members in making strategic data-related decisions by analyzing,
manipulating, tracking, internally managing and reporting clinical data.
Implement primary and exploratory statistical analysis as requested by Senior Biostatisticians or other researchers.
Do extensive programming and analysis in SAS including BASE, STAT, IML, GRAPH, Report, ODS, SQL, SAS ACCESS and SAS Macros on Unix and Windows, SQL programming, and SPLUS/R, and Shell Scripting Language.
Perform and implement clinical data snapshots, database lock including interim data, final data, available to company personnel and regulatory agencies when required. Create, validate, document, and archive clinical data targeted for regulatory submission.
Monitor and improve quality of electronic data and information services - develop and implement processes and tools to facilitate this mandate (e.g. data checking, program validation, data monitoring).
Assist in reviewing CRFs to ensure that all captured data follow the rules and outlined by the protocol.
Interact internally and externally with clinical investigators, agency representatives and regulatory bodies when required.
Review internal processes and design and implement electronic solutions and software systems (including applications, programs and other information systems) to help our group maximize its quality and productivity
Train and mentor Junior SAS programmers, graduate Statistics students and fellows. Participates in selection processes for recruitment and hiring of Junior SAS programmer staff; provides input into the performance evaluations of Junior SAS programmers.
Assisting the IT Director in determining the priorities of SAS programming tasks and sets targets to meet the Group’s objectives.
Under the guidance of the Group Statistician and the IT Director, work with other SAS team members in development, review, maintenance, and training of SOPs, working instructions and other controlled documents in the SAS team. Maintain documentation of changes and report back to appropriate groups and committees.
Develop and implement project plans related to SAS application development and data production. Provide expertise to members of the Statistics and Information Technology Group for complex issues with a goal of increasing efficiency and effectiveness ensuring accordance with acceptable research standards and clinical trials methodologies. Develop and maintain a process to ensure compliance to SOPs, and to ensure SAS programming consistency across studies and other program. Identify areas in which new SOPs or processes are required; this may include review of the SAS program validation plans, and data checking plans (data edit specifications).
Master’s in Statistics or a related field
Minimum of 5 years of Biotech/Pharmaceutical industry or clinical trials research organization experience.