Zymeworks

Principal Statistical Programmer

Clinical Development - Vancouver, BC Canada

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 Senior Director, Biometrics and will be based in Vancouver, BC or Seattle, WA.

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, regulatory submissions (e.g., DSURs, NDAs/BLAs, briefing documents), publications, and presentations.
• Develops and maintains standard SAS macros, templates, and programming standards for biometrics department.
• Develops and maintains SDTM and ADaM data set specifications for clinical studies.
• Programs SDTM and ADaM data sets for clinical studies.
• Reviews and contributes to the development of statistical analysis plans, TLF specifications, study CRFs, edit check specifications, and database design specifications.
• Programs SAS edit checks and reports to assist data management’s data cleaning activities.
• Performs and manages critical tasks involved in the assembly of the module 5 data package for NDAs/BLAs.
• 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 Experience

• Bachelor's degree in a computer science, mathematics, statistics, or health-related field.
• A minimum of 8 years of relevant experience, including experience in the pharmaceutical or life sciences industry.
• 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.
• Knowledge of FDA regulatory requirements and ICH/GCP guidelines preferred.
• Knowledge of CDISC standards.<.li>
• Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines, with background in oncology preferred.
• 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.
• 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.
• An equivalent combination of education and experience may be considered.
• 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.

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 www.zymeworks.com.

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

How to Apply

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.

Zymeworks

Zymeworks is an Equal Opportunity Employer

Submitted: 03/06/2021