Bala Cynwyd, PA, USA
One of our leading client, A global clinical company and leading specialty provider of clinical trial services is searching for a Manager, Clinical Programming. In this role, the person selected will lead and manage programming activities for ongoing projects that require Adjudication of EndpointsThese opportunities are direct-hire or contract-to-perm roles. If you are interested in aligning with a highly regarded organization that values quality and integrity and fosters an environment where teamwork and professionalism thrive, then don't hesitate to contact Rose Chu, VP in Pharmaceutical & Biotech Services Group at 610-822-1256 for questions. Company offer abundant opportunities for motivated pharmaceutical professionals to pursue their scientific/clinical interests, make an impact and maximize their growth potential. Please find the qualifications and requirements below. If you feel that this position is one that you are excited about and qualified for, please send over your most recent CV. We are always interested in talking to candidates for current AND future opportunities Please respond directly at [Click Here to Email Your Resumé] with your resume attached –WORD document Responsibilities: Collaborate with Clinical, Data Management and Project Management teams to help support by providing programming support for adjudication of endpoints/outcome events Discuss with Clinical trial leaders and develop strategies for identification of endpoints defined in the Charter/Protocol documents Author specifications as per the charter-defined event identification strategy for programmatic identification of events as per the charter definition. Lead and Manage Endpoint Adjudication programming activities that include dataset specification, development, generation & validation of datasets, Summaries, Patient profiles and Data listings for ongoing clinical trials Develop data transfer documents for active studies and lead exchange of clinical and adjudicated data between vendors/CROs/sponsors Develop customized graphical displays as per the statistical analysis plan/charter, perform data integrity checks and ensure correctness of data displays. Manage multiple projects and develop global tools to improve programming efficiency and quality Responsible for creating documentation through specification development, programming and validation for future reference and for internal control purposes. Perform exploratory programming for statistical analysis and ad hoc analysis Requirements: 10 years of SAS programming experience supporting analysis and reporting for Phase I / Phase II, Phase III and Phase IV clinical trials data. Experience in mapping clinical study data to standard/submission/repository data models and programming experience converting raw data to the data models. Proven experience in developing data transfer documents and leading exchange of clinical data between vendors/CROs/sponsors. Strong Base SAS and SAS Macro programming skills. Proven skills in the development and review of SAS programs, macros/utilities, debug macros within a clinical trials environment. Proven experience in developing programs to check adjudicated data quality, ensure consistency and compliance to CDISC data guidelines , data transfer agreements. Ability to develop programs converting raw data to standard format as per the business rules. Generate Flat files - Delimited Text/Excel files/ODS, summaries , graphs, listings, narratives and reconciliation outputs for ongoing clinical trials. Programming experience supporting Oncology, Cardiovascular, CNS, Infectious disease and device related studies. As a well-funded clinical company, company pays highly competitive salaries and a comprehensive benefits package. Interested individuals are encouraged to contact or submit their CV to the following email address: [Click Here to Email Your Resumé] Search Terms: manager of clinical programmer, Lead clinical SAS Programmer, Senior Statistical Programmer, Lead Statistical Programmer, SAS Programmer, Clinical SAS Programmer, SAS Analyst, statistical programming, clinical data, SAS Software, CDISC, SAP, CDISC validation, OpenCDISC, ADaM datasets, CDISC compliant, SAS macros, Statistical Analysis Plan, clinical trials, SAS Base/Stat/Macro/GRAPH, MS in statistics. MS in Mathematics, Statistics, statistics management We appreciate your understanding, in that; we will only be able to respond to those inquiries who meet the stated requirements. To protect our client's interests, we will not be responding to inquiries that do not contain a CV/Resume. Finally, please include the position ID (rc- Manager, Clinical SAS) in the subject line of your correspondence to ensure review. Please forward your credentials in Word format through Indeed or call Rose Chu at 610-822-1256 for questions. Our clinical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews. Rose Chu Vice President – Pharmaceutical, CRO, Biotech, Medical Device Global Employment Solutions/Fahrenheit IT P (610)822-1256 | C (215)-317-2999 | F (610-668-5000) | [Click Here to Email Your Resumé] One Presidential Blvd. North, Suite 310, Bala Cynwyd, PA 19004 We're looking for hot talent Tell your friends and get $250 plus a new iPad 2, iPad Mini, Apple Sport Watch or iPod Touch. Sign up 10 years of SAS programming experience supporting analysis and reporting for Phase I / Phase II, Phase III and Phase IV clinical trials data.