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Xenon Pharmaceuticals Inc.

Senior Biostatistician 2

Posted 3 Days Ago
Be an Early Applicant
Hybrid
Boston, MA, USA
155K-173K Annually
Senior level
Hybrid
Boston, MA, USA
155K-173K Annually
Senior level
Provide biostatistical support for clinical development programs, including protocol development, statistical analysis plans, analysis specifications, statistical programming, data management input, CRO oversight, and review of scientific reports. Collaborate cross-functionally on clinical deliverables, ensure compliance with SOPs, FDA regulations, ICH guidelines, and CDISC standards, and support ad hoc analyses, manuscripts, presentations, and potential NDA/MAA submissions.
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Who We Are:

Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics 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 product pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 and XEN1720 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are being developed for pain. 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 Biostatistician 2 to join our team. The Senior Biostatistician 2 will be a key member of a highly collaborative Clinical Development team. This is a hands-on role.

This position reports to the Director, Biostatistics, and will be based out of Boston, MA, USA in our Needham office. For Boston based candidates, this is a hybrid position, requiring a minimum of 2 days per week in the office. We may consider remote locations for an exceptional candidate. The level of the position will be commensurate with the candidate’s education and industry experience.

RESPONSIBILITIES:

  • Provide statistical support for assigned clinical development programs or trials.

  • Participate in the development of study protocols, develop statistical analysis plans, and analysis specifications for the programming implementation of statistical analyses.

  • Provide statistical input into data management and programming deliverables (e.g. data collection tools, analysis datasets) to ensure that they support the protocol specified goals and statistical analyses.

  • Develop statistical programs, as needed, in support of ad-hoc requests, manuscripts and presentations and provide statistical review of scientific reports and publications.

  • Collaborate with other functional areas on project deliverables and timelines within the area of responsibility.

  • Provide oversight of CRO deliverables within the area of responsibility to ensure quality and accuracy.

  • Adhere to the company and department SOPs and working practices.

  • Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics

  • Other duties as assigned

QUALIFICATIONS:

  • A Senior Biostatistician 2 will have a PH.D. in Statistics or Biostatistics with a minimum of 2 years of statistical experience in the pharmaceutical or biotech industry, or Master with a minimum of 5 years of statistical experience

  • Up-to-date knowledge of statistical methodologies related to areas such as clinical trial design, statistical modeling and analysis

  • Knowledge of applicable FDA regulations and ICH guidelines

  • Advanced knowledge of the SAS programming language; knowledge of R or similar language a plus

  • Knowledge of CDISC standards, including ADaM requirements

  • Experience in CNS preferred

  • Experience in CRO management preferred

  • Experience in NDA/MAA submission a plus

  • Strong organizational and time management skills, and the ability to prioritize multiple deliverables and ad-hoc requests.

  • Strong communication skills, both oral and written

  • Strong interpersonal skills, ability to build credibility and trust inside and outside the Company

  • Ability to travel up to 10%, both domestically and internationally

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.

Xenon Pharmaceuticals Inc. Needham, Massachusetts, USA Office

117 Kendrick Street , Suite 200, Needham, MA, United States, 02494

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