Principal Statistical Programmer

Cytel Inc. seeks Principal Statistical Programmer in Waltham, MA to provide leadership in promoting communication and adequate information flow to motivate, encourage, and align statical programmers on the strategic objectives of the production of SDTM and Analysis datasets and ensure that the regulatory requirements are met through validation and compliance activities. Lead and contribute to statistical programming activities on FSP projects (development or QC of deliverables). Ensure an efficient collaboration with BDM teams in Europe and India. Accountable for the quality, traceability, reproducibility, and timeliness of statistical programming deliverables. Maintain a detailed project and validation plan. Communicate with internal and external clients. Ensure budget monitoring and adherence. Ensure the statistical programming systems, processes, and deliverables are aligned with the relevant regulatory requirements including: Clinical study reporting ICH E3, Electronic records handling Chapter 21 of the US Code of Federal Regulation - Part 11, and electronic submission of clinical data to agencies -CTD guidance and CDISC SDTM and ADaM standards100% telecommuting permitted.

Requirements: Master's Degree in Medical Bioinformatics, Biomedical engineering, Pharmacy, Chemistry or other health related fields and 2 years of experience in SAS programming with clinical trial data, including two years with each of the following: (1) overseeing statistical programming support for Phase II & III clinical trials; (2) reviewing the production and validation analysis data sets, including metadata mapping specifications, consistent with CDISC (SDTM and ADaM) standards; (3) reviewing project work of SAS BASE, STAT, MACRO and ODS to develop TLFs, reports, ad hoc analysis, and other CSR/e-submission deliverables based on SAP; (4) and ensuring project collaboration with cross-functional teams including biostatistics and data management. Will also accept a bachelor's degree in the same fields and 5 years of experience with each requirement listed above. Interested candidates should email resume to krzysztof.orzechowski@cytel.com listing the job title and job code 13707 in the subject line.