Senior/Principal Statistical Programmer

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 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. Xenon's proprietary, pediatric formulation of ezogabine, XEN496, is being studied in a Phase 3 clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. 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 with valued collaborators. 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 Senior or Principal Statistical Programmer to join our team. The Senior or Principal Statistical 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 statistical analysis plans, ICH guidelines, and applicable regulatory requirements. The ability to work independently and expert SAS/Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT programming experience is required.

This position reports to the Director, Statistical Programming 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, including managing CROs to ensure deliverables are accurate and compliant.
• Act as a Programming SME for assigned studies, including authoring/reviewing programming specifications, such as SDTM/ADaM specifications, TFLs creation and QC for reporting events, eSUB packages, and documenting production and validation programs.
• Apply programming skills to support statistical analysis, clinical reporting, regulatory submissions, Ad-Hoc/post-Hoc requests, and scientific publications.
• Work with Biostatistics and other functions for the development and maintenance of the data review and reporting tools, e.g., aCRF, SAP, and mock review, and any other statistical applications as appropriate.
• Work with CRO counterpart on project timeline management; oversee and provide input on statistical programming activities, ensure timely and quality delivery.
• 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 statistical 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.

QUALIFICATIONS:

• A minimum of a bachelor's degree in a scientific, computer science or related field, training in statistics preferred.
• A Principal Statistical Programmer requires a minimum of 8 years of statistical programming. An equivalent combination of education and experience may be considered.
• A Senior Statistical Programmer requires a minimum of 5 years of statistical 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 for clinical trials TFL report and/or integrated analysis for regulatory submissions.
• Hands-on experience and in-depth knowledge in CDISC standards, including SDTM and ADaM, controlled terminologies, aCRF, cSDRG, ADRG, Pinnacle 21 reports, and define xml.
• Excellent knowledge of SAS/Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT; advanced SAS programming ability to implement standard statistical analyses; experience in developing SAS macros to standardize the workflow and internal processes.
• Experience in CNS, pediatric rare disease area preferred.
• Experience in CRO management.
• Strong communication, leadership and interpersonal skills required.

To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.

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