Job Description
Cytel Inc. seeks a Senior Statistical Programmer in Waltham, MA to support or lead one or more Phase I-IV clinical trials across a variety of therapeutic areas using advanced knowledge of CDISC standards (SDTM & ADaM) and advanced SAS programming skills. Perform data manipulation, analysis, and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming including SAS BASE, STAT, MACRO, SQL, and Graph. Generate and validate CDISC, SDTM, and ADaM datasets; analysis files; and tables, listings, and figures (TLF), aligned with regulatory requirements and industry best practices including ICH E3 and 21 CFR Part 11. Perform production, quality control (QC) and validation programming. Generate complex ad-hoc reports utilizing raw data. Apply strong understanding of and experience with efficacy analysis. Communicate with and respond to internal cross-functional teams and external stakeholders for project specifications, status, issues, or inquiries. 100% telecommuting permitted.
Minimum Requirements: Master's degree in Statistics, Computer Science, Health Care Administration, or related health science field plus two years of employment experience with SAS programming with clinical trial data. Employment experience must include 2 years with: CDISC SDTM Standards; Clinical Data Validation; and Creation and Review of CRFs. Will also accept a bachelor's degree in the same fields and plus five years of employment experience with SAS programming with clinical trial data. Employment experience must include 2 years with: CDISC SDTM Standards; Clinical Data Validation; and Creation and Review of CRFs. Interested candidates should send resume to Krzysztof.Orzechowski@cytel.com listing the job title and job code 13710 in the subject line.