Clinical Programming Lead
1 month ago
About Xenon Pharmaceuticals Inc.
Xenon Pharmaceuticals Inc. is a leading biotechnology company advancing innovative treatments for epilepsy and depression. Our mission is to develop novel therapies that address unmet medical needs, and we are seeking a highly skilled Associate Director/Director, Clinical Programming & Data Standards to join our team.
Job SummaryWe are looking for a seasoned professional with expertise in clinical programming, data standards, and SAS programming to lead our Clinical Programming team. The successful candidate will be responsible for developing, maintaining, and validating SAS computer programs that access, visualize, and report clinical trial data. This role requires strong technical leadership, excellent communication skills, and the ability to work independently.
Key Responsibilities- Lead and manage all Clinical Programming activities on project or study level using eDC and external raw data.
- Work cross-functionally to define and implement a data visualization environment, enabling data review for medical monitoring and clinical analysis.
- Lead efforts to programmatically improve the efficiencies of CDMs 'processes as they relate to data monitoring and cleaning.
- Program data listings to support ongoing Medical Monitoring review of data, specifically AE data to facilitate AEs/Events of Special Interest adjudication.
- Create data visualizations, including dashboards, to present clinical data effectively.
- Contribute to the development and review of Standard Operating procedures (SOPs), related to clinical data management programming.
- Conduct Clinical Programming to support clinical data management, data cleaning and data review, as well as external data reconciliation, in accordance with standards/SOPs or study specific guidelines.
- Perform data checks as needed to ensure integrity and correctness of data.
- Program Patient Profile listings, incorporating external data, and exception reports.
- Perform QC/validation of clinical data listings and edit checks.
- Develop and maintain SAS macros, templates and utilities for data cleaning and reporting following good programming practices.
- Develop and propose short- and long-term goals for the department in accordance with overall Company strategies.
- Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company's Human Resource policies and practices
- Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any
- A minimum of a bachelor's degree in a scientific, computer science or related field, training in statistics preferred.
- Must have a minimum of 5 years' experience in a data management programming lead position.
- Knowledge of multiple phases of clinical development and experience in using SAS, or equivalent programming language, for clinical trials
- Hands-on experience and in-depth knowledge in CDISC standards is preferred
- Excellent knowledge of SAS/Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT
- Experience in CNS, pediatric rare disease area preferred.
- Solid analytical and proactive problem-solving skills.
Xenon Pharmaceuticals Inc. offers a competitive compensation package, including a base salary range of $153,200 to $209,000 CAD, as well as a comprehensive benefits program, including medical, dental, vision, short- and long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
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