Job description
Who We Are:
At Xenon Pharmaceuticals (NASDAQ: XENE), we are committed to providing a brighter future for patients suffering from neurological disorders. Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver innovative medicines for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.
What We Do:
We are advancing an exciting pipeline of neurology-focused therapies, with a focus on commercializing novel treatments for epilepsy. Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 Phase 3 epilepsy program includes studies in adult patients with focal onset seizures and primary generalized tonic clonic seizures. In addition, XEN1101 is being evaluated as a treatment for major depressive disorder in both a company-sponsored Phase 2 clinical trial, as well as an investigator-led proof-of-concept study. We are also proud of the leading-edge science coming out of our discovery labs, where many innovative, early-stage research programs are underway. In addition to these proprietary programs, our pipeline includes clinical-stage partnered programs. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.
About the Role:
We are seeking a Clinical Data Programmer to join our Data Management team. The Clinical Data Programmer will provide expert-level hands-on principal programming support and technical leadership to develop, maintain, validate, and run SAS computer programs that access, visualize, analyze, and report clinical trial data, in accordance with data review plans, ICH guidelines, and applicable regulatory requirements. The ability to work independently and exhibit expertise in SAS programming is required.
This position reports to the Senior Director, Data Management and will be located in the Boston, MA, USA location; we may consider other US locations for an exceptional candidate.
RESPONSIBILITIES:
- Manage programming activities on project or study level.
- 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 SAS macros, templates and utilities for data cleaning and reporting.
- Follow good programming practices, create, and validate global SAS macros and utilities to automate standard and frequent tasks, enhance quality and efficiency.
- Create standard SAS macro library; maintain and update existing SAS macros; keep good documentation of programming work.
- Support the development of clinical programming SOPs and standard processes as needed.
- 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.
- Other duties as assigned.
- A minimum of a bachelor’s degree in a scientific, computer science or related field, training in statistics preferred.
- A Clinical Data Programmer requires a minimum of 4 years of clinical programming. An equivalent combination of education and experience may be considered.
- Experience in a pharma, biotech, or CRO environment is required.
- 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.
- Strong communication and interpersonal skills required.