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.
Zymeworks is seeking a highly-motivated professional who is looking to grow their career with our company.
- 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, data management and medical writing
- Responsible for statistical aspects of projects, including experimental design, sample size estimation, subject randomization, data management, 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 data management and analysis work performed by staff and by contract research organizations
- Provides consultation with clinical scientists 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
- Oversees and coordinates user acceptance testing (UAT) when electronic data capture systems are being implemented for studies. Performs UAT, as needed
- Reviews and approves study database specifications, data management plans, 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, programming, and data management 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 data management and statistical programming activities
- Writes appropriate Standard Operating Procedures (SOPs)/training guidelines for data management, 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
Qualifications and Experience
- PhD in biostatistics, statistics or other relevant scientific discipline and a minimum of 10 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
- 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
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 http://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 opportunity, please forward your cover letter and resume to firstname.lastname@example.org.
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