Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. 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.
Zymeworks is seeking a highly motivated professional who is looking to grow their career with our company. This position will be based in our Seattle office and will report to the Director, Biometrics.
- Drives statistical strategy for one or more indications within a therapeutic area for clinical development plans and for global regulatory submissions to ensure evidence-based decision making, operations and execution. Achieves objectives in creative and effective ways.
- Provides statistically sound experimental design and data analysis inputs to optimize drug development programs, meet project objectives, and regulatory requirements.
- Provides statistical input on the design of clinical trials. Proposes study designs, performs power/sample size calculations, writes the statistical section of protocols, participates in CRF development and IXRS set up.
- Writes Statistical Analysis Plans (SAP) for clinical trials and develops TLF shells and output specifications based on SAP.
- Participates in the set up and oversight of data/safety monitoring committees.
- Contributes to the creation of regulatory submissions. Provides statistical and writing input and manages the analysis and data reporting activities for submissions.
- Attends meetings and teleconferences with regulatory authorities and represents Zymeworks statistical position.
- Works on extremely complex problems. Exercises independent judgement in selecting and adapting, as necessary, methods appropriate for the specific objective. Provides statistical expertise.
- Manages and oversees the production of TLFs by the SAS programming group. Participates in the validation and QA of analysis data sets and TLF output.
- Develops and contributes to the maintenance of department tools, templates, guidelines, SOPs and systems.
- Manages and oversees CRO data analysis activities including TLF and SAP review, budget management, and planning of analyses,
- Participates in the writing and review of publications, including manuscripts, posters and abstracts.
- Leads through example to establish an environment fostering effective and collaborative working relationships.
Qualifications and Experience
- MS preferably in statistics or biostatistics and 8+ years of experience
- Proven interpersonal skills and the ability to lead through example and to establish an environment fostering effective and collaborative working relationships
- Good organizational skills and the ability to work effectively in a high paced, fast changing environment. Results-oriented
- In-depth knowledge in a range of statistical methodologies
- Excellent knowledge of SASâ and good programming practices
- Proficiency with EASTâ is a plus
- Knowledge of the drug development process and FDA/ICH regulations and guidelines
- Experience in the design, analysis and reporting of clinical trials across a range of therapeutic areas (oncology preferred)
- Knowledge of CDISC standards
- Strong oral and written communication skills with the ability to clearly communicate statistical thinking and ideas
- Demonstrated high level of integrity and ethics
- Detail oriented with excellent analytical problem-solving skills
- Proficiency in Microsoft Word, Excel, PowerPoint, and SharePoint
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
Due to the high volume of applicants, only those selected for interviews will be contacted.