Principal Statistical Programmer

October 2

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Clinical Outcomes Solutions

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Patient Reported Outcomes • Health Economics and Outcomes Research • Clinical and Observational Research Design and Execution • Outcomes Regulatory Support • Statistics and Psychometrics

51 - 200

Description

• Join our PBS division. • Exercise your strong communication and leadership skills to support or lead clinical trials. • Report to the Director, Statistical Programming. • Provide significant technical expertise for statistical programming. • Develop automated reports and submission data standard packages. • Support statistical programming activities for multiple and/or large/complex projects. • Develop and execute statistical analysis and reporting deliverables. • Design and maintain statistical datasets for multiple stakeholders. • Collaborate with statistics and project stakeholders for efficient execution with high-quality deliverables. • Serve as programming point of contact throughout the product lifecycle. • Ensure analysis and report programming adheres to global and departmental standards. • Maintain and manage project plans including resource forecasting. • Coordinate supplier programming activities and interact with client statistical programmers. • Utilize strong project management skills to engage key stakeholders. • Design and develop complex programming algorithms. • Comprehend analysis plans and statistical methodology. • Utilize expertise in CDISC and ADaM standards for clinical trials.

Requirements

• Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. • 7-8 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with good knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines. • Study lead experience working with cross functional teams, including leading programming teams. • Strong experience in QCing and validating work of other programmers, preferably outsourced work. • Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience. • Strong proficiency implementing the latest CDISC SDTM / ADaM standards. • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. • Submissions experience utilizing define.xml and other submission documents. • Excellent analytical & troubleshooting skills. • Ability to provide quality output and deliverables, in adherence with challenging timelines. • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

Benefits

• Our collaborative working environment encourages innovation and rewards results. • We offer an excellent benefit’s package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us!