Data Analyst

Octagon Research Solutions has the domain expertise and a robust process to address our client’s submission-critical CDISC SDTM data conversion projects. Our process is tightly integrated with our Regulatory Submission services, leveraging the experience gained from successfully completing well over 200 submissions. 

 

Our SDTM-related experience includes a track record of over 100 studies (2,500 datasets) converted across these 8 therapeutic areas: Analgesia, Anesthesiology, Anti-inflammatory, Endocrinology, Gastroenterology, Neurology, Oncology (general and pediatrics), and Pulmonary.  Supporting the process is an enterprise ETL (extract, transform, load) software tool that has a feature-rich visual development environment.

 

We are the established leaders in data conversion. If you are looking to join an organization with innovative and effective processes, data conversion strategy and smooth execution, Octagon is the place for you!

 

Prior knowledge may include:

· Strong data management knowledge and skills is advantageous for this position! The ideal candidate should have clinical data management experience, especially exposure to protocol assessment, Case Report Form design, understanding of clinical data management systems, study start up (database administration, edit check creation/validation) and data base lock. They should also have experience in taking a lead role in studies. This is a great role and one that is slightly away from the somewhat mundane tasks of data cleaning and discrepancy management!!

 

· Strong database administration knowledge and skills is advantageous for this position! The ideal candidate should have experience performing the duties of a Clinical Data Management System (CDMS) database support specialist, troubleshoot errors, instruct other Data Management staff in the proper use of CDMS, create and test the CDMS set up for new studies/projects, create and test data entry screens, write data entry guidelines, program and test the automated edit checks to be executed for the study/project, create and test files necessary for the electronic upload of data, and upload electronic data received through external sources (e.g., central laboratories).  They should also have experience in taking a lead role in studies. This is a great role and one that is away from the ordinary tasks associated with databases and provides the opportunity to get involved in multiple aspects of data conversion!

 

· Experience producing derived / analysis datasets from raw / CDMS-based datasets would also be advantageous for this position!  As an alternative career path, the ideal candidate should have experience: reviewing source data and annotated Case Report Forms; developing, reviewing and/or utilizing database mapping specifications used to produce analysis datasets from source datasets; and implementing programs to accomplish the mapping outlined by these specifications.  It is a great opportunity to learn new tools and techniques to accomplish a familiar, business critical task.

 

Technical responsibilities may include the following tasks:Review and analysis of source (raw) dataAuthoring of mapping specifications from source (raw) data to target (CDISC SDTM and/or sponsor defined standards)Development of CDISC SDTM domains utilizing a data conversion toolQuality Control of CDISC SDTM domainsCreation of data definition files and Case Report Forms annotated to CDISC SDTM

 

Team responsibilities:Understand the scope and timeframe for completion of the assigned tasksUnderstand and follow Octagon’s SOPsParticipate in project / team meetingsCreate meeting agendas / minutesAssist with project status report and project related documentationProactively identify issues and contribute to solutionsDemonstrate teamwork skillsEnsure quality for internal and external deliverablesExhibit commitment and confidence

 

The successful candidate will have a combination of the following skills/experience:

 A Bachelor’s Degree in a scientific, analytical, business or technical discipline, targeted technical training or relevant work experience3+ years of industry experience (Pharmaceutical, Biotechnology, or CRO)Experience in interacting with a project teamPossess the ability to effectively manage time, prepare for meetings and prioritize project workDemonstrates verbal/written communication skillsHaving what it takes to be successful:Reliability - “Do you perform consistently?  Are you able to follow through on your assignments?”Flexibility - “Are you adaptable to a fast pace, service-oriented environment?”Effective communication - “Are you a good listener?  Can you communicate constructively?”Problem solving - “Are you a problem solver who bring suggestions?”Commitment - “Do you strive to excel in your career?”

 

Desired Qualifications:

 Clinical Data Management experience Basic SAS knowledge CDISC SDTM exposureExperience with an ETL tool such as Oracle Warehouse Builder (OWB), Informatica PowerBuilder, IBM PowerStage or Microsoft SQL Data Transformation Services (DTS)

 

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. 

 

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 of Talent Acquisition at LKoch@octagonresearch.com .