Principal Statistician

Clinical Research Seattle, Washington


Description

Why Work for Us?

Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care

We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

Company Description

Zymeworks is a 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.

Zymeworks is seeking a highly-motivated professional who is looking to grow their career with our company.  

This position will report to the V.P of Biometrics and will be based in Seattle, WA.

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such. To be considered fully vaccinated, all 3 doses are required.

Key Responsibilities

  • 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.
  • Collaborates with Medical Monitors to propose statistically sound clinical trial designs that are appropriate with respect to the current treatment landscape. Tasks includes performing power/sample size calculations using statistical software or simulations to generate the operating characteristics for the trial.
  • Writes the statistical sections of protocols.
  • Participates in CRF development and IXRS set up.
  • Writes Statistical Analysis Plans (SAP) for clinical trials.
  • Develops TLF shells and output specifications based on SAP.
  • Participates in the set up and oversight of data/safety monitoring committees.
  • Manages and contributes to regulatory submission documents such CSR/ISS/ISE/eCTD documentation for clinical trials.
  • Attends meetings and teleconferences with regulatory authorities and represents Zymeworks statistical position. Contributes to relevant sections of the briefing books for various regulatory meetings.
  • Develops and contributes to the maintenance of department tools, templates, guidelines, SOPs and work instructions.
  • Manages and oversees CRO 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 Education

  • Ph.D in Statistics/Biostatistics and a minimum of 4+ years of relevant experience or
  • M.S in Statistics/Biostatistics with and a minimum of 5+ years of relevant experience or
  • An equivalent combination of education and relevant experience may be considered.

Skills and Abilities

  • Experience in the design, analysis and reporting of oncology clinical trials preferred. Experience in other therapeutic area may be considered.
  • Proficiency with EASTâ is preferred.
  • Knowledge of CDISC standards is required.
  • In-depth knowledge of statistical methodologies.
  • Knowledge of the drug development process and FDA/ICH regulations and guidelines.
  • Excellent knowledge of SASâ and good programming practices.
  • 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. 
  • 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.

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.

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