Zymeworks

Company Description

Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. Zymeworks' suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop antibody-based therapeutic candidates. We are a global company headquartered in Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and Redwood City, CA.

Why Work With Us

Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

This role will be located in Redwood City and is hybrid with a minimum of 3 days per week onsite.

What You'll Do

• Oversee and provide statistical support to the development of Zymeworks pipeline in close collaboration with clinical development, regulatory affairs, drug safety, clinical pharmacology, data management, biomarker/translational sciences and program management team members.
• Grows, develops and oversees operations and management of the functional areas of biostatistics, and statistical programing. Responsible for driving optimal study designs, data collection, analytic approaches, and rigorous interpretation of data. Ensures systems capabilities and resources are in place to optimize design, conduct, analysis and interpretation of data. Set statistical standards and methods to ensure quality delivery of clinical, translational medicine, and pharmacology datasets, all in coordination with each function and with data management.
• Provides strategic guidance for all biostatistics-related activities related to various programs, regulatory activities, and oversight of the contractors and/or CRO’s with primary responsibility for these activities. Plans, organizes and directs analysis work performed by staff and by contract research organizations.
• Collaborates with product development team (PDT) regarding the conduct of studies, data management, statistical methodology, data analysis and interpretation and regulatory submissions.
• Oversee, author (as needed), review and approve protocols, SAPs, CRFs, CSRs, associated publications and other study/program level documents.
• Reviews and approves study database specifications, data transfer plans, CDISC and ADaM specifications, and ensures reviews as needed by other key stakeholders.
• Provides an interface between internal study teams and external data management, statistical, and programming vendors to ensure appropriate communications and vendor relationships
• Recruits and selects vendors, consultants and contractors responsible for providing data management, statistical and statistical programming services to the company. Negotiates the scope of work and cost of services for data management, statistical, and statistical aspects of projects. Ensures that projects are conducted within budget and in a timely and quality manner.
• Oversees statistical and programming, activities related to company programs either internally or through active and effective management of outside contractors and/or CRO’s.
• Ensures adherence to quality control procedures for statistical programming activities.
• Writes appropriate Standard Operating Procedures (SOPs)/training guidelines for, statistical, and statistical programming activities.
• Works with project management to establish and ensure statistical, programming, and data management project deliverables meet expected timelines.
• Provides strategic guidance for all biostatistics-related activities related to various programs, regulatory activities, and oversight of the contractors and/or CRO’s with primary responsibility for these activities.
• Leads through example to establish an environment foster effective and collaborative working relationships

What You'll Bring

• PhD in biostatistics, statistics or other relevant scientific discipline and a minimum of 8 years’ related experience in the pharmaceutical industry at either a contract research organization or pharmaceutical/biotech company or an equivalent combination of education and experience.
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships
• Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment
• Knowledge of FDA, EMA and ICH regulatory guidelines, clinical development process, clinical trial design, statistical programming, data analysis and data management
• Experience with regulatory agency (FDA and EMA) interactions
• Knowledge of SAS and other statistical programming packages
• Strong math and analytical skills are essential to complete job requirements successfully
• Able to think and act strategically, anticipate road-blocks and orchestrate plans to resolve issues and mitigate risks
• Strong oral, written and listening skills
• Demonstrated high level of integrity and ethics
• Proficiency with MS Office

Total Rewards

We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.

The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).

Our total rewards package that includes:

• Industry leading vacation and paid time off
• Exceptional medical, dental and vision benefits by country
• Zymelife health and wellness benefits
• Matching RRSP / 401K / Pension program
• Employee Share Purchase Program
• Employee Equity Program
• Paid time off to volunteer in your community

This role is not eligible for relocation or immigration support.

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.

NOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.