The Principal Statistical Programmer provides programming expertise in support of the clinical development process. This includes developing SAS programs to monitor, analyze, and report clinical trial data and managing programming activities and deliverables for contract programmers and external vendors. Acts as a liaison between data management, biostatistics, and clinical operations as needed. . The primary focus is to ensure that product and study level deliverables are completed on time, of high quality, and in accordance with company, industry, and regulatory requirements. The secondary focus is to engage in the enhancement clinical programming processes and infrastructure.
* Develops SAS programs to analyze and report clinical trial data for CSRs, annual reports, regulatory submissions and publications with a focus on accuracy, completeness, quality, and timely delivery * Manages programming activities and deliverables for contract SAS programmers and external vendors. Ensuring programming is conducted according to departmental and industry standards * Develops and maintains standard SAS macros, templates, and programming standards for biometrics department * Develops and maintains CDISC-compliant SDTM and ADaM data set specifications for clinical studies * Programs CDISC-compliant SDTM and ADaM data sets for clinical studies * Participates in the review of statistical analysis plans, study CRFs, edit check specifications, and database design specifications * Programs SAS edit checks to assist data management's data cleaning activities * Contributing to the development of departmental utilities, processes, procedures, and statistical computing environment * Assists in the preparation of NDAs/BLAs * Assists in the development and writing of departmental SOPs * Provide technical support and guidance to more junior programmers when required * Performs other responsibilities as assigned
* Ten or more years of relevant experience, including experience in the pharmaceutical or life sciences industry * Knowledge of FDA regulatory requirements and ICH/GCP guidelines preferred * Expertise with CDISC standards * 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 pharmaceuticals industry and clinical trial data setting is required * Demonstrated understanding of and experience with clinical trial data and data manipulations, analysis and reporting of analysis results * Excellent application development skills required * 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 simultaneously 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
* Experience with oncology clinical studies * Experience with additional programming languages and tools such as R, SPSS, Perl, VBA, MS Access, MS Excel, and SQL that interface with SAS
* Bachelor's or higher degree in a computer science, mathematics, statistics, or health-related field (or equivalent) * BS and 8+ years or MS/PhD and 6+ years of software development and/or programming experience in the Biotech, Pharmaceutical, Medical Device, and Health Care industries. Degree in computer science, mathematics, statistics, or health-related field
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
About Seattle Genetics
Seattle Genetics is dedicated to improving patient outcomes through advanced antibody-drug conjugate technology designed to deliver cell-killing agents directly to tumor cells.