- Position will function independently to provide statistical programming technical leadership to support team members;
- Independently design and code complex SAS programs for applications designed to analyze and report complex clinical trial data for electronic submissions of data in CDISC format;
- Provide guidance on the resolution of highly complex clinical trial reporting problems within budget and timeline constraints while assuring high quality standards;
- Perform quality control checks of advanced SAS code and output produced by other statistical programmers;
- Maintain working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry;
- Identify problems and develop global tools to increase efficiency and capacity of the statistical programming group; conduct briefings and participate in technical meetings for internal and external stakeholders;
- Manage project timelines and schedules of specific phases of projects and contracts with internal personnel and outside stakeholders.
- The position requires a Bachelor’s degree (or foreign equivalent) in Biostatistics, Statistics, or Computer Science, or a related field plus two (2) years of experience in the job offered or in a related position.
- Experience must include: Demonstrable experience with SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH;
- Demonstrable knowledge of review and understand study documents like Protocol, Case Report Forms, Statistical Analysis Plan and Tables/Figures/Listings shells;
- Demonstrable knowledge of electronic submissions in eCTD structure including creating submission documents like annotated Case Report Forms, Define.xml, Reviewers Guide and datasets in CDISC SDTM and ADaM standards;
- Demonstrable experience performing quality control of outputs like SAS datasets and Tables/Figures/Listings and narratives produced by other Statistical Programmers;
- Demonstrable basic knowledge of ICH, GCP, Regulatory requirements and Clinical Trials.
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition.