Director, Biostatistics and Programming at BioTalent Canada

Department: Clinical Development

Workplace Type: Hybrid

Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific and 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.

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.

Zymeworks is proudly headquartered in our brand new, net-zero facility located in the vibrant Main St biotech hub of Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and the Bay Area.

This role will be based out of Redwood City, CA and is hybrid with a minimum of 3 days per week onsite.

Key Responsibilities

• Participates in the development of strategic and long-term direction of the Biometrics group. Works with senior management team to develop and implement programs, strategies and processes. Ensures department and operational activities are aligned with corporate objectives.
• Grows, develops and oversees operations and management of the functional areas of biostatistics, statistical programing
• Responsible for statistical aspects of projects, including experimental design, sample size estimation, subject randomization, statistical analyses and presentation of data.
• Ensures systems capabilities and resources are in place to optimize design, conduct, analysis and interpretation of clinical and non-clinical data.
• Plans, organizes and directs analysis work performed by staff and by contract research organizations.
• Provides consultation with Clinical Development team regarding the conduct of studies, data management, statistical methodology, data analysis and interpretation and regulatory submissions.
• Provides biostatistics responses to statistical aspects of regulatory negotiations. Ensures that all work meets appropriate regulatory requirements.
• Writes and, when applicable, reviews and approves statistical methods sections of study protocols, statistical analysis plans, statistical analyses and statistical input to reports and publications.
• Responsible for case report design and review for studies.
• 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 tatistical 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.

Education and Experience

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.

Skills and Abilities:

• 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 package.
• 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 US base salary range for this full time position is $180,000 – $276,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location.

The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. 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).

Please note that the compensation details listed in role postings reflect the base salary only, and do not include bonus, equity, or benefits.

• Industry leading vacation and paid time off
• Excellent health and wellness benefits
• Zymelife health and wellness benefits
• Paid time off to volunteer in your community
• Matching country specific pension savings program
• Employee Share Purchase Program
• Employee Equity Program

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.