Associate Director, Statistical Programming at Vertex Pharmaceuticals
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.
The Associate Director, Statistical Programming is responsible for providing support and technical guidance on clinical project teams. This individual will lead the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. This individual will participate in departmental and cross functional technology development and process improvement initiatives.
- Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDlSC SDTM format
- Provides guidance on the resolution of highly complex clinical trial reporting problems within budget and time line constraints, while assuring high quality standards
- Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
- Responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry
- Manages project timelines and schedules of specific phases of projects and contracts with internal personnel and outside customer representatives
- Conducts briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMEA) on assigned projects
- May supervise other statistical programming staff
- PREFERRED QUALIFICATIONS:
- Masters Degree in Biostatistics, Mathematics, Statistics, Computer Science, Life Science M.S. (or equivalent degree) and 10+ years of relevant work experience
- Experience with creating all files, documents, and analyses necessary to support electronic submissions in eCTD format, including ISS/ISE
- Experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
- Experience with the CDISC SDTM and AdaM models and transforming raw data into these standards
- Experience working with all types of safety data and coding dictionaries commonly used by the pharmaceutical industry
- Experience working in a team environment providing technical leadership and solving clinical trial reporting problems of moderate to high complexity within budget and customary time line constraints while assuring high quality standards
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 at ApplicationAssistance@vrtx.com.