Shire Pharmaceuticals- Sr. Statistical Programmer- Wayne, PA
From sasCommunity
Shire Pharmaceuticals, Inc. Senior Statistical Programmer
Founded in 1986, Shire Pharmaceuticals, Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.
Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our continued growth, we currently have a need for Senior Statistical Programmer in our Wayne, PA location.
Description
The Senior Statistical Programmer will provide statistical programming support for the creation and maintenance of integrated analysis data sets for all assigned projects.
Key Responsibilities
• 75% - Support projects through the creation and maintenance of analysis data sets, integration of safety and efficacy data, production/validation of ouput, and review of annotated case report forms • 15% - Collaborate 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 • 10% - Contribute to departmental process and standards initiatives such as SDTM, ADaM, TFL4 Shire
Education and Experience Requirements
• Bachelor’s degree in a scientific field • Minimum 5 years’ statistical programming experience using SAS in the pharmaceutical, contract research organization, or other clinical research setting • Master’s of Science degree preferred
Key Skills and Competencies
• Experience integrating data sets from archived and current studies • Experience managing programming activities and collaborating with other functions • Experience in developing project plans including time and resource estimates • Experience using industry standards for data set design as defined by Clinical Data Interchange Standards Consortium (CDISC) • Knowledge of appropriate FDA and other regulatory (e.g. ICH) guidance • Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS SQL • Experience using SAS version 8.2, 9.1.3, or 9.2 • Proficiency in developing own code as well as modifying existing code • Experience producing detailed and accurate documentation for statistical programs • Experience working with CROs and other Service Providers • Excellent analytical, problem solving, and organization skills with the ability to work on multiple tasks • Flexibility changing priorities, detail-oriented, work 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, the ability to work in a collaborative environment, and desire to improve skills are essential • Experience in development and implementation of statistical programming standards is preferred • Knowledge of software systems development is preferred • SAS/GRAPH a plus • Ability to travel approximately 5% of time is required
To create a profile and apply online, go to https://v2.projectix.com/shire/jobboard/JobDetails.aspx?__ID=*1F42CE72B7977984
Additional information can be found at www.TimeToBeBrave.com
Shire is committed to providing high quality, competitive and appropriate health care benefits for employees and their families.
Shire is an Equal Employment Opportunity and Affirmative Action Employer.
