Senior Statistical Programmer - Shire (Wayne, PA)

This individual will provide statistical programming support for the creation and maintenance of integrated analysis data sets for all assigned projects.

Supports projects through the creation and maintenance of analysis data sets, integration of safety and efficacy data, production/validation of output, and review of annotated case report forms (75%)

Collaborates with project/study Biostatisticians and Statistical Programming Managers in the creation, implementation, and maintenance of programming development plans for each project/study accounting for timelines, resources, and quality deliverables for all project/study assigned; ensure that all programming has been carried out per appropriate validation program standards; along with appropriate documentation within the programs (15%)

Contributes to departmental process and standards initiatives such as SDTM, ADaM, TFL4Shire (10%)

Requirements

• Bachelor's degree in a scientific field required, Master of Science degree preferred
• At least 5 years of statistical programming experience using SAS in the pharmaceutical, contract research organization, or other clinical research setting
• Must have experience integrating data sets from archived and current studies
• Must have experience managing programming activities and collaborating with other functions
• Experience in developing project plans including time and resource estimates
• Experience in development and implementation of statistical programming standards is preferred
• Knowledge of software systems development is a plus
• Experience using industry standards for data set design as defined by Clinical Data Interchange Standards Consortium (CDISC)
• Knowledge of appropriate FDA and other regulatory (i.e., ICH) guidances
• Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS SQL; SAS/GRAPH a plus. Experience using SAS version 8.2, 9.1.3 or 9.2
• Proficient in developing own code as well as modifying existing code
• Experience producing detailed and accurate documentation for statistical programs
• Excellent analytical, problem solving and organization skills with the ability to work on multiple tasks
• Flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tasks
• Excellent communication skills (verbal and written) as well as good interpersonal skills
• Strong organizational skills and the ability to work in a collaborative environment, and desire to improve skills are essential
• Experience working with CROs and other Service Providers

URL: www.datashaping.com/jobs18168x.shtml
Please mention datashaping.com when applying. Thank you.