Director/Senior Director, Biostatistics and Programming
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. To learn more about job opportunities at Xenon, please visit www.xenon-pharma.com.
We are seeking a Director/Senior Director, Biostatistics and Programming to join our team. The Director/Senior Director, Biometrics develops statistical and data management plans for the Company’s products and product candidates in all phases of clinical development (Phases 1-4). The Director/Senior Director will be a key member of a highly collaborative Clinical Development team and lead and manage both direct reports and external consultants and CRO’s.
The Director/Senior Director, Biostatistics and Programming will have proven leadership ability in a fast paced, multi-location environment and interact with all levels of internal staff as well as external stakeholders, including, but not limited to the FDA and other health authorities, CRO’s, Key Opinion Leaders and Advisory Boards and Committees.
This position will be located in the Vancouver area, BC, Canada or the Boston area, MA, USA; we may consider other locations for an exceptional candidate.
- Develop and propose Statistical Analysis Plans for the Company’s portfolio of product candidates from Phase 1 through Phase 3, New Drug Application(s) and post approval studies in compliance with global regulatory standards and in collaboration with other key functional areas, external vendors and advisors.
- Provide statistical input to a wide variety of scientific, clinical development and regulatory document types including Clinical Development Plans, protocols, synopses, Investigator Brochures, regulatory submissions and responses, and scientific publications and presentations.
- Represent the Company and Biostatistics function in interactions, both in writing and in person, with the FDA, EMA and other Health Authorities.
- Represent the Company at scientific and medical meetings, including, for example, Investigator Meetings, Advisory Boards, and other interactions with Key Opinion Leaders.
- Oversee the biostatistics function in CRO’s; manage scope of work and relationships with other external statistician consultants as needed.
- Oversee the programming function internally and in CRO’s to ensure outputs are as planned.
Maintain current knowledge of relevant issues related to statistics and trial design, drug development, Health Authority regulations, and competitive trends to inform input and recommendations.
- Develop and maintain relevant Standard Operating Procedures and other policies, procedures and systems relevant to the department.
- Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
- Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and 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.
- PhD in Statistics or other relevant discipline with a minimum of 10 years of experience in a pharma or biotech environment, MSc and relevant experience may be considered; specific experience in neurology, rare disease and/or adaptive trial design is highly desirable.
- Deep and broad experience in all aspects of Phase 1 to 3 clinical trial design, execution and data interpretation in both efficacy and safety; ideally has had a lead role in developing Statistical Analysis Plans for NDA preparation and defense.
- Experience in CRO selection, contracting and management.
- Excellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company.
- Proven ability to build and develop high performing teams; excellent delegation and conflict resolution skills.
- Be science and data driven while at the same time, creative and flexible in strategic thinking and problem solving.
- Ability to travel up to 10%, both domestically and internationally.
To apply for this position, visit our job posting here and 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.