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Clinical Trial Programming Specialist
2 months ago
We are seeking a highly skilled and experienced Statistical Programmer Lead to join our team at Everest Clinical Research Services Inc. As a key member of our programming team, you will be responsible for leading complex statistical programming projects and ensuring the delivery of high-quality results.
Key Responsibilities- Lead projects with higher levels of complexity, challenge, and difficulty, and lead efforts to resolve complex statistical programming issues or problems.
- Apply project management skills and statistical programming techniques to lead assigned projects, achieving on-time delivery of deliverables with quality, and earning client trust and repeat business.
- Represent the company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming oversight, project cost estimates, and proposal development.
- Under supervision, represent the company to interact with regulatory agencies regarding matters relating to responsible projects/programs.
- Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
- Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company or client Standard Operating Procedures (SOPs) and project-specific requirements.
- Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE.
- Perform CDISC standard compliant checks on SDTM and ADaM datasets, generate, review, and resolve Pinnacle 21 validation issues, and perform additional QC checks using company Working Instruction (WI) checklists.
- Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client.
- Create SDTM and ADaM define.xml files, and table of contents, and perform QC review of these files prepared by others.
- Participate and/or lead programming teams in support of product regulatory submission related activities.
- Perform quality review/assessment on regulatory submission programming documents, datasets, computer programs, etc.
- Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers, and develop new macros and utilities.
- Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance.
- Complete job-required and project-specific training, comply with applicable company and trial Sponsor's Policies, SOPs, and WIs, document data and programming information in accordance with corporate SOPs and guidelines, and archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines.
- May lead programming efforts for assigned client clusters when required.
A Master's or Ph.D. degree in Statistics, Biostatistics, Epidemiology, and Computer Sciences, with at least 8 years of experience in clinical trial statistical programming, or a Bachelor's degree in the above fields with at least 10 years of experience in clinical trial statistical programming.
