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Summary of job:
To support the Oncology Business Group Biostatistics team by carrying out and conducting programming activities of statistical programmers, and coordinating with external vendors (as required), Statisticians, and other business functions to ensure timely and accurate programming and validation activities for clinical studies. Contributes to the overall efficiency and best practice running of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.
Provide statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinate programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (Client), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications)
Access and convert data to SAS from Database management system and PC file formats (e.g., MS Excel, text files)
Work with external vendors in order to develop or monitor the content and structure of SAS data sets
Develop and maintain SOPs, SWPs and other related technical documents, providing input to the Database and CRF Development
Provide input in developing statistical analysis plans, producing specifications of analysis datasets, validation plans, and other related documents
Maintain standards for programming activities (SDTM, ADaM, directory structure, etc.), and guiding/coaching Statistical programmers
Work independently as well as in teams to accomplish tasks and goals defined by supervisor
Attend required training and meetings and bringing in new ideas to improve the programming process
Minimum of Bachelor?s degree in Statistics, Computer Science, Mathematics, or a related science discipline (Masters preferred)
Minimum 8 years? experience in SAS programming in biostatistics department environment for phase I-IV clinical trials in a pharmaceutical/CRO environment
Strong technical skills and Oncology experiences supporting submissions
SDTM and ADaM technical knowledge
Good understanding with different phases of clinical trials, protocols, and CRF designs
Lead Programmer experience
Strong managerial / technical understanding of programming and clinical related issues along with an ability to demonstrate significant leadership of SAS programming technical activities in a clinical pharmaceutical/CRO environment
Understanding of submission-related activities and experience with agency-related requirements
Oncology and in-depth ADaM programming
Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office
Proven experience with UNIX and Windows operating systems
Understanding of the software development life cycle
Understanding of FDA guidelines
Knowledge of agency requirements including ICH, FDA, and other guidance
Knowledge of current FDA submission process (Define.xml, etc.)
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
Proactive and effective working
Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required
*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role*?
Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascents fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.
If you are ready to propel your career to new heights read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.
Associated topics: application architect, backend, back end, c/c++, c#, devops, matlab, programming, project architect, software engineer lead
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.