Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.
- Responsible for the direction, planning, execution and reporting of statistical analyses with clinical data to the highest quality standards.
- Responsible for building effective vendor relationships. This includes being involved in RFP development, contract negotiation and selection of CROs and/or technology.
- Develops Statistical Analysis Plans (SAPs) and manages the execution of analyses and validation of results.
- Responsible for the statistical design of clinical trials, including authorship of statistical sections of protocols.
- Responsible for preparation of specifications for study tables, listings and figures (TLFs).
- Performs statistical analyses using packages such as SAS and R in support of presentations, publications, advanced and exploratory analyses, prototyping of standard outputs and general study reporting.
- Reviews draft eCRFs, programmed edit checks and data transfer specifications to ensure that all data necessary to meet the objectives of the study are collected appropriately.
- Participates in the review of clinical data, including specification of custom review listings and programmatic data checks.
- Represents the Statistics function on study teams.
- Defines and implements documentation and archival standards for Statistics deliverables and ensures that study documentation is in an audit-ready state.
- Contribute to the development, maintenance and governance of standards, including SOPs, TLF standards and guidelines for Statistics work processes.
- Ensures that statistics deliverables are produced in accordance with GCP, internal SOPs and all regulatory requirements.
Education and Experience
Ph.D. or M.S. degree in statistics, mathematics, or a closely-related statistical discipline. Pharmaceutical or relevant clinical CRO experience, including 7+ years in clinical statistics. Previous experience with statistical packages including SAS and a sound understanding of statistics and programming concepts.
Skills and Abilities
- Strong knowledge of drug development processes.
- Proven success in management of statisticians and contract service providers.
- Excellent leadership, collaboration, communication and decision making skills.
- Knowledge of FDA/ICH guidelines and industry standard practices.
- Working knowledge of submission requirements, e.g., Biologics License Applications (BLA) and New Drug Applications (NDA).
- Independent, innovative, and creative thinker.
- Ability to multi-task as needed in a dynamic environment.
- Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
Why Work for Us?
Zymeworks’ employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
How to Apply
If you are interested in this challenging and rewarding position, please email your resume and cover letter to firstname.lastname@example.org with “Director, Biostatistics” in the subject line.