Director of Biostatistics and Programming

4 days ago

Redwood City, California, United States Zymeworks Full time
Job Summary

Zymeworks is a leading biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative biotherapeutics. We are seeking a highly skilled Director of Biostatistics and Programming to join our team in Redwood City, CA. This is a hybrid role with a minimum of 3 days per week onsite.

Key Responsibilities
  • Develop and implement strategic plans for the Biometrics group, ensuring alignment with corporate objectives.
  • Grow and develop operations and management of biostatistics and statistical programming functional areas.
  • Lead statistical aspects of projects, including experimental design, sample size estimation, subject randomization, statistical analyses, and data presentation.
  • Ensure systems capabilities and resources are in place to optimize clinical and non-clinical data design, conduct, analysis, and interpretation.
  • Plan, organize, and direct analysis work performed by staff and contract research organizations.
  • Provide consultation with Clinical Development teams on study conduct, data management, statistical methodology, data analysis, and regulatory submissions.
  • Develop and review statistical methods sections of study protocols, statistical analysis plans, statistical analyses, and statistical input to reports and publications.
  • Review and approve study database specifications, data transfer plans, CDISC and ADaM specifications, and ensure reviews as needed by other key stakeholders.
  • Interface with internal study teams and external data management, statistical, and programming vendors to ensure effective communications and vendor relationships.
  • Recruit and select vendors, consultants, and contractors for data management, statistical, and statistical programming services.
  • Oversee statistical and programming activities related to company programs, either internally or through management of outside contractors and/or CROs.
  • Ensure adherence to quality control procedures for statistical programming activities.
  • Develop Standard Operating Procedures (SOPs) and training guidelines for statistical and statistical programming activities.
  • Work with project management to establish and ensure statistical, programming, and data management project deliverables meet expected timelines.
  • Provide strategic guidance for biostatistics-related activities, regulatory activities, and oversight of contractors and/or CROs.
  • Lead by example to foster effective and collaborative working relationships.

Requirements
  • PhD in biostatistics, statistics, or a relevant scientific discipline, with a minimum of 8 years' related experience in the pharmaceutical industry.
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
  • Excellent organizational skills and the ability to manage concurrent deliverables 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 interactions.
  • Knowledge of SAS and other statistical programming packages.
  • Strong math and analytical skills.
  • Able to think and act strategically, anticipate roadblocks, 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

Zymeworks offers a comprehensive total rewards package, including 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 for this role is $180,000 - $276,000 USD per year (US).

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