Senior Biostatistician 2

Xenon Pharmaceuticals•Needham, MA

3d•Hybrid

About The Position

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.

Requirements

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 CDISC standards, including ADaM requirements
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

Nice To Haves

knowledge of R or similar language a plus
Experience in CNS preferred
Experience in CRO management preferred
Experience in NDA/MAA submission a plus

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