Senior/Principal Statistical Programmer

Who We Are:

Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. 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 product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 "X-NOVA" clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. 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/Principal Statistical Programmer, to join our team. This position 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 Senior Director, Statistical Programming and will be located in Boston, MA, USA location. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate's education and industry experience.

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.

• 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.

• Apply programming skills to support statistical analysis, clinical reporting, regulatory submissions, Ad-Hoc/post-Hoc requests, and scientific publications.

• 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

• 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 minimum of 5 years (8 years for principal) of statistical programming experience in a pharma, biotech, or CRO environment.

• 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, 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.

• An equivalent combination of education and experience may be considered.

The base salary range for this role is $147,000 to $173,300 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.

Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.

Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.