Boston, MA, USA Req #158
Monday, February 6, 2023
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:
About the Role:
We are seeking a Biostatistician/Senior Biostatistician to join our team. The Biostatistician/Senior Biostatistician will be an important member of a highly collaborative Clinical Development team. This is a hands-on role.
This position reports to the Senior Director, Biostatistics and Programming and will be located in the Boston, MA, USA location; we may consider other locations for an exceptional candidate.
- Provide statistical support for assigned clinical development programs or trials.
- Input into 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 area of responsibility.
- Provide oversight of CRO deliverables within 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.
- Some international travel may be required.
- Other duties as assigned.
- Biostatistician level requires PhD 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 4 years of experience. An equivalent combination of education and experience will be considered.
- Senior Biostatistician level requires PhD in Statistics or Biostatistics with a minimum of 3 years of statistical experience in the pharmaceutical or biotech industry, or Master with a minimum of 6 years of experience. An equivalent combination of education and experience will be considered.
- 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.
- 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.
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.