Senior Biostatistician

Boston, MA, USA Req #137 Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is committed to delivering innovative medicines to provide a brighter future for patients suffering from neurological disorders. 

At Xenon, we are advancing an exciting pipeline of neurology-focused therapies, with a particular emphasis on novel treatments for both adult and pediatric patients with epilepsy. XEN496 is currently being evaluated in the Phase 3 “EPIK” clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. Late-stage development plans are also underway for our XEN1101 program, building upon the compelling data from the Phase 2b “X-TOLE” study in adult patients with focal epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, with many early-stage research programs underway. In addition to Xenon’s proprietary programs, we have ongoing collaborations with our valued pharmaceutical partners. With a healthy balance sheet to support our growth plans, we continue to build a fully-integrated, premier neuroscience company with strong discovery, development, and commercial operations.

Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver new medicines for patients in need. Building and maintaining a respectful, collaborative, inclusive, and productive culture is a priority for us.  We are looking for great people who thrive in a fast-paced, dynamic work environment to join our team during this transformative time for Xenon.

We are seeking a Senior Biostatistician to join our team. The 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 preferably be located in the Boston, MA, USA location area. We will consider the following remote locations for an experienced candidate: NY, NJ, DE, CT.
 

RESPONSIBILITIES:

• 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.

QUALIFICATIONS:

• 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.
• 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.