Statistical & Computer Systems Compliance Analyst - Queens University

Reporting to the Chief Information Officer (CIO), the Statistical and Computer Systems Compliance Analyst will have the opportunity to work on a wide range of statistical and IT projects, helping to ensure that the applications released are of the highest quality. Responsibilities include validation of computer systems originating within the computing team or with other CCTG groups, including risk assessment; interpreting applicable guidelines, regulations, standards and policies as they relate to IT systems, processes and procedures; developing and implementing policies and procedures.

View full job description here.

KEY RESPONSIBILITIES:

• Perform validation of computer systems including identifying areas requiring validation, coordinating validation initiatives and projects originating within the computing team or with other CCTG groups, preparation of plans and reports, as well as lifecycle documentation.
• Collaborate on computer system risk assessments with respect to the security and integrity of systems and data, as well as their compliance; including but not limited to assessments of audit trail, access control and data management.
• Interpret guidelines, regulations, standards and CCTG policies to ensure current IT systems, processes and procedures are compliant; including monitoring and ensuring required changes are integrated in a timely manner.
• Develop and maintain computing team policies and procedures including access control, validation and change control; ensure that policies and procedures are adhered to.
• Assist the Group Statistician and the Chief Information Officer (CIO) in preparing for computer system audits and inspections by regulatory agencies and partners.
• Complete action plans, including initiating and coordinating system change control, as per CCTG procedures.
• Maintain inventory of audit/inspection findings related to IT; proactively identify, analyze, and mitigate risks; develop and implement corrective action plans.
• Provide input regarding the use of data by the computing team for various projects lead by other CCTG groups.
• Execute other duties as required by the CIO such as acting as liaison between the computing team and internal groups on specific project, as assigned by the CIO.

REQUIRED QUALIFICATIONS:

• A university degree in statistics, computer science, management information systems, or a related discipline.
• Several years (5 minimum) experience in statistical analysis and/or information systems management, preferably in a regulated environment.
• Demonstrable knowledge and experience with data analysis and visualization tools (such as SAS, Excel, Tableau, SQL, R, Python) is required.
• Database management experience is considered an asset.
• Consideration may be given to an equivalent combination of education and experience.

SPECIAL SKILLS:

• Respects diversity and promotes equity and inclusion in the workplace.
• Knowledge of guidelines and regulations related to computer system validation, such as GCP, FDA 21 CRF Part 11 and GDPR.
• Excellent oral communication and presentation skills and the ability to write clear and detailed instructions.
• Ability to cooperate in a team environment.
• A desire to develop new methods to improve existing programs and practices.
• Strong organizational skills.
• Strong analytical and critical thinking skills to evaluate data and identify trends and patterns of interest.
• High level of motivation and the ability to work well independently and as part of a team.
• Ability to liaise effectively with CCTG staff as well as external contacts.
• Ability to manage multiple priorities in a fast-paced, deadline driven environment.
• An appreciation for best practices, compliance, and confidentiality.

DECISION MAKING:

• Write and review standard operating procedures and work instructions with a focus on IT processes. Ensure appropriate processes are in followed including obtaining the required approvals.
• Determine relevant policy and procedures for various tasks. Identify improvement opportunities and address inconsistencies with team practices.
• Determine requirements, organization, content, and format of documentation.
• Recommend plan of action for completing project milestones.
• Schedule and delegate work for self and collaborate with other team members.
• Contribute to the content and format of training programs.
• Regular handling of sensitive and confidential information for which discretion is required.