Senior Biostatistician 2/Principal Biostatistician

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 Biostatistician 2 or Principal Biostatistician to join our team. The Senior Biostatistician 2 or Principal Biostatistician will be a key member of a highly collaborative Clinical Development team. This is a hands-on role.

This position reports to the Director or higher, Biostatistics and Programming, 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 other locations for an exceptional candidate. The level of the position will be commensurate with the candidate's education and industry experience.

RESPONSIBILITIES:

• Provide statistical leadership for assigned clinical development programs or trials.
• Participate in the development of study protocols, write the statistical section 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 and write statistical sections of regulatory documents.
• 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 and ensure policies are understood and followed by direct reports, if any.

QUALIFICATIONS:

• A Principal Biostatistician will have a PH.D. in Statistics or Biostatistics with a minimum of 4 years of statistical experience in the pharmaceutical or biotech industry, or Master with a minimum of 7 years of experience.
• 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 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.
• 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.

The base salary range for this role is $114,000 to $160,200 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.

As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position.

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.

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.