Senior Clinical SAS Programmer
Octagon Research Solutions, Inc., is a fast growing Development Partnering Organization (DPO), which acts as a virtual partner in supporting its Biopharmaceutical & Pharmaceutical clients throughout the entire clinical research, development and submissions process. Based in Wayne, PA, Octagon meets their client's unmet needs by integrating information technology and multidisciplinary services to create a complete solution. We offer unparalleled practical knowledge and industry expertise that spans the clinical research and development lifecycle.
The Senior Clinical SAS Programmer creates SAS programs in support of sponsor's clinical trials according to SOPs and guidelines. This programmer will create, document, validate, process, and maintain statistical programs and macros that generate analysis datasets, tables and graphics with high quality per agreed timelines. As a project lead the Senior Clinical SAS Programmer will provide direction and oversight to programmers in creating sponsor deliverables.
Based in our Wayne, PA office, the Senior Clinical Programmer's primary responsibilities will include the following:
- Act as lead programmer to write SAS programs that produce analysis datasets and analyses specified in the Statistical Analysis Plan
- Act as quality control programmer to validate SAS programs that produce analysis datasets and analyses specified in the Statistical Analysis Plan
- Assist the Manager of Clinical programming in overseeing the daily tasks associated with clinical programming and subsequent analysis to ensure sponsor deliverables are created per agreed timelines and to high quality standards
- Ensure SAS programs adhere to SOPs, guidelines, and specifications
- Ensure SAS program output matches the requirements of the Statistical Analysis Plan
- Consult with managerial, statistical, data management, DIS, and medical writing personnel to clarify program intent, identify problems, and suggest changes
- Design and/or review database structure
- Create derived-analysis datasets
- Execute analyses specified in the Statistical Analysis Plan (SAP) or Report and Analysis Plan (RAP) under the guidance of the project statistician
- Take instructions and perform tasks as necessary as directed by reporting manager
- Ensure specifications and documentation are correct and complete
- Work with other team members to ensure outputs are correct and complete
- Mentor others in programming and program coding
- Organize, plan, and prioritize work to develop specific goals and plans to prioritize, organize, and accomplish project objectives
- Analyze information and evaluate results to choose the best solution and solve problems
- Perform programming in support of sponsor ad hoc requests
- Produce special reports to comply with regulatory requests
- May interact directly with sponsors to facilitate project completion
The successful candidate will have a combination of the following skills/experience:
- Minimum 6 years SAS programming experience in the pharmaceutical, biotechnology,
- and/or contract research organization industries
- Extensive knowledge of Base SAS, SAS/GRAPH, SAS/STAT, and ODS
- Experience working with heterogeneous data structures
- Ability to work independently and adept at managing multiple competing tasks
- Good understanding of clinical data and pharmaceutical development
- Knowledge of SDTM, ADaM, FDA and ICH guidance
- Knowledge of clinical trial conduct and the data and reporting requirements for clinical trials
- Knowledge of SAS programming techniques needed to produce outputs in accordance with specifications
- Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
Octagon is an Equal Opportunity Employer with an outstanding corporate culture. We are an emerging growth company providing a business casual environment, strong benefits, competitive compensation and outstanding career advancement opportunities. The entrepreneurial setting, coupled with our financial stability, has made us an employer of choice, and one of the most sought after Life Sciences employers in the area. Please visit us at www.octagonresearch.com to learn more about how we are revolutionizing the drug development lifecycle.
To apply, please forward your resume to Laurie Koch, Recruitment Manager, Talent Acquisition at lkoch@octagonresearch.com.
|