Zymeworks

Associate Director of Statistical Programming

Clinical Research - United States

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 or may be remote.

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

Key Responsibilities

• Effectively manages a group of full time and contract statistical SAS programmers by holding regular meetings, coaching, goal setting, yearly performance reviews, and resolving issues.
• Uses creative thinking and broad expertise to develop innovative and efficient programming solutions to analyze complex clinical trial data.
• Provides leadership for programming activities to support clinical trials. Acts as a key collaborator and strategic partner with biostatistics in ensuring that drug-development plans are executed efficiently with timely and high-quality deliverables.
• Leads a team of programmers for successful regulatory submission of clinical trials.
• 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 to assist data management’s data cleaning activities.
• Develops and maintains SDTM and ADaM data sets specifications for clinical studies.
• Programs SDTM and ADaM data sets for clinical studies.
• Develops SAS programs to analyze and report clinical trial data for CSRs, regulatory submissions (e.g., DSURs, NDAs/BLAs, briefing documents), publications, and presentations.
• Performs and manages critical tasks involved in the assembly of the module 5 data package for NDAs/BLAs.
• Ensures departmental compliance to CDISC and FDA standards for submitting data, programs, and analyses for regulatory submissions.
• Drives the strategy for maintaining and enhancing the current programming infrastructure.
• Establishes and maintains programming standards, global SAS macros libraries and templates to ensure efficient and consistent programming across all clinical studies.
• Develops and maintains the SAS environment and license for the biometrics department.
• Develops and maintains SOPs and work Instructions to comply with regulatory requirements.

Qualifications and Education:

• Bachelor's degree in a computer science, mathematics, statistics, or health-related field and a minimum of 12 years of relevant experience, including experience in the pharmaceutical or life sciences industry or an equivalent combination of education and experience may be considered.
• 4+ years of management experience.
• Regulatory submission experience is required.
• Extensive knowledge of CDISC standards and familiarity with SEND standards required.
• 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.
• 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.

Skills and Abilities

• Proficiency in SAS and other statistical software such as R.
• Demonstrated ability to lead and develop a team of motivated SAS programmers.
• Proven ability to collaborate with other groups in clinical development and within Biometrics.
• Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.

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: 07/02/2022