Senior Biostatistician 2 at Xenon Pharmaceuticals Inc. in Boston

Job description

• Application
• 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

Requirements

• 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

Skills

Required

• FDA regulations and ICH guidelines
• SAS programming language
• Interpersonal skills

Preferred

• R or similar language
• Experience in CNS
• Experience in CRO management
• Experience in NDA/MAA submission

Benefits

• 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.