Senior Statistical Programmer

Clinical Research Seattle, Washington United States


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 either Vancouver, BC. / Seattle, WA.

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such.

Key Responsibilities

  • Participates in statistical programming activities, acting as a key collaborator and strategic partner with biostatistics in ensuring that drug-development plans are executed efficiently with timely and high-quality deliverables.
  • Develops SAS programs to analyze and report clinical trial data for CSRs, Integrated Summary of Safety (ISS), regulatory submissions (e.g., DSURs, NDAs/BLAs, briefing documents), publications, and presentations.
  • Develops and maintains SDTM and ADaM data set specifications for clinical studies.
  • Programs SDTM and ADaM data sets and TLFs for clinical studies.
  • Reviews and contributes to the development of statistical analysis plans, TLF specifications, study CRFs, and database design specifications.
  • May develop and maintain standard SAS macros, templates, and programming standards.
  • Implements and maintains programming standards and procedures for biometrics department, ensuring quality results.
  • Uses creative thinking and broad expertise to develop innovative and efficient programming solutions to analyze complex clinical trial data.
  • Ensures departmental compliance to CDISC and FDA standards for submitting data, programs, and analyses for regulatory submissions.

Qualifications and Education

  • Bachelor's degree in a computer science, mathematics, statistics, or health-related field.
  • A minimum of 5 years of relevant experience, including experience in the pharmaceutical or life sciences industry. An equivalent combination of education and experience may be considered.

Skills and Abilities

  • Excellent knowledge of SAS programming and applications in the pharmaceutical/biotechnology industry.
  • Demonstrated understanding of and experience with clinical trial data and data manipulations, analysis and reporting of analysis results.
  • Knowledge of CDISC standards.
  • Knowledge of FDA regulatory requirements and ICH/GCP guidelines preferred.
  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines, with background in oncology preferred. 
  • Experience with safety reporting.
  • Excellent overall computer proficiency required (PC-Windows preferred) and proficiency in Microsoft Word, Excel, PowerPoint, and SharePoint.
  • Clear and concise verbal and written communication skills.
  • Detail oriented with excellent analytical and problem-solving skills.
  • Ability to prioritize and handle multiple tasks and projects in a fast-paced environment.
  • Ability to work independently and in a highly collaborative team environment.
  • Dedication to quality and reliability in all work tasks.
  • Self-motivated, eagerness to grow professionally and commitment to self-development.
  • Embody and champion Zymeworks’ values: Act with Integrity. Collaborate. Care.
  • Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.

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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