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Please let me know onsha...@riderconsultinginc.com if you have any good resources available for the below position. Role: SAS - Biostat Programmer Location : Woodcliff Lake, NJ Duration: Long Term Interview: Telephonic / Skype Job Description: Main duties/responsibilities: - Providing statistical programming and validation support for clinical study reports, 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: 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). Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). Working with external vendors in order to develop or monitor the content and structure of SAS data sets. - SDTM and ADAM technical knowledge are preferred. In addition, knowledge of agency requirements including ICH, FDA, and additional guidance is beneficial. Knowledge of current FDA submission process (Define.xml, etc.) is strongly recommended. Developing and maintaining SOPs, SWPs and other related technical documents, providing input to the Database and CRF Development. Providing input in developing statistical analysis plans, producing specifications of analysis datasets, validation plans, and other related documents. Good understanding with different phases of clinical trials, protocols, and CRF designs. -Maintaining standards for programming activities (SDTM, ADaM, directory structure, etc.), and guiding/coaching Statistical programmers. - Working independently as well as in teams to accomplish tasks and goals defined by supervisor. Attending required training and meetings and bringing in new ideas to improve the programming process. Qualifications and Education required: Minimum of Bachelor's degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred. Candidates with a domestic degree are preferred Experience required: Minimum 3 years' experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment. 6+ years' experience preferred. Recent Oncology experience preferred Majority of experience in a pharmaceutical programming environment or demonstrated significant leadership of SAS programming activities in a clinical pharmaceutical/CRO environment. Skills and aptitude required: Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. Knowledge of SDTM and ADaM standards. 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. Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required Shalin Patel | Sr. Recruiter | T: 872 356 8008 | email id: sha...@riderconsultinginc.com Rider Consulting Inc | 50 Cragwood rd, suite 205, South Plainfield, New Jersey | www.riderconsultinginc.com -- You received this message because you are subscribed to the Google Groups "US_IT.Groups" group. To unsubscribe from this group and stop receiving emails from it, send an email to us_itgroups+unsubscr...@googlegroups.com. To post to this group, send email to us_itgroups@googlegroups.com. Visit this group at https://groups.google.com/group/us_itgroups. For more options, visit https://groups.google.com/d/optout.
