Senior Biostat Programmer
 Advanced Clinical | |
 United States, Illinois, Deerfield | |
| 6 Parkway North (Show on map) | |
 Jan 08, 2025 | |
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OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Senior Biostat Programmer in the East Coast time zone. The Senior Biostat Programmer role will support the Biostatistics team by carrying out programming activities of statistical programmers and work closely with clinicians, programmers, study team and publication managers to generate and QC outputs; and ensure timely and accurate programming and validation activities for clinical studies and publications. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES * Providing statistical programming and validation support for clinical study reports, and publications. Overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests. Work with the clinical study team on study design, development and/or review of clinical study protocols. * Develop and/or review statistical analysis plans, including Table/listing/figure shells, and final study report for clinical studies; perform post-hoc statistical analyses as needed. Work closely with clinicians, statistician, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies. * Work with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. * Providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management. Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents. * Work independently to accomplish tasks and goals defined by supervisor and bringing in new ideas to improve the programming process and maintaining standards for programming activities. * Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of CRO deliverables and may work on submission teams as a statistician and/or a programmer EXPERIENCE Minimum of 7 years of experience in the pharmaceutical, CRO, or biotech industry required EDUCATION Minimum of Bachelor's Degree required, Master's in Biostatistics/Statistics preferred To be a best-fit your strengths must include: * Strong SAS programming skills, with experience in SAS-Base, MACRO, STAT, and GRAPH. * Strong CDISC data standards, e.g. SDTM and ADaM * Good technical writing skills. * Good communication skills with strong verbal, written and interpersonal communication skills. * Strong organizational skills with ability to effectively manage multiple projects. * Strong teamwork ability/commitment and individual initiative. * Proven experience with UNIX and Windows operating systems. * Understanding of the software development life cycle. * Understanding of FDA guidelines. * Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. * Applies good judgment and demonstrates initiative to resolve issues. About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com. Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. | |