• Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred. Strong educational background is expected.
• Minimum 8 years’ experience in SAS programming in biostatistics department environment for phase I-IV clinical trials in a pharmaceutical/CRO environment. Lead Programmer experience is expected.
• 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 expected. Define.XML knowledge and familiarity with a submission process is preferred.
• Oncology and in-depth ADaM programming required. Submission support with compliance is expected.
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. Proactive and effective working. Accountable. Leadership expected.
• Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required
To support the 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.
Strong technical skills and Oncology experiences supporting submissions are required.
1. 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 (ISE), 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.
2. SDTM and ADaM technical knowledge required. In addition, knowledge of agency requirements including ICH, FDA, and other guidances is strongly recommended. 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.
3. Maintaining standards for programming activities (SDTM, ADaM, directory structure, etc.), and guiding/coaching Statistical programmers.
4. 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.
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