Senior Statistical Programmer

CRO - Statistical Programmer role

Job Primary Functions

• Perform the role of the Lead Statistical Programmer
• Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
• Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
• Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs and Reviewers Guides to support SDTMs and ADaMs
• Develop specifications for SDTMs and ADaM datasets
• Review SAPs and TFL shells from a programming perspective for studies
• Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs
• Present and share knowledge at department meetings
• Respond to QA and client audits, and support qualification audits
• Identify processes within programming that will increase productivity, quality and efficiency

Job Qualifications

• Bachelor's degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects
• Typically 3 - 5 years of SAS® programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
• Previous Lead experience as a Statistical Programmer within a biotech, CRO or pharma company
• Excellent organizational, time management and project management skills with team leadership experience, as demonstrated by ability to organize and motivate project teams and the ability to delegate and prioritize work to meet project timelines
• Knowledge of CDISC requirements
• Previous oncology experience desired but not essential
• Positive attitude and willingness to learn and contribute in a team setting and communicate effectively within the team environment
• Good organization skills and the ability to prioritize own work
• Self motivation and ability to work independently
• A cooperative and team-oriented approach

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