| SAS Clinical Developer (Prefer local profile to Princeton NJ) at Princeton, New Jersey, USA |
| Email: [email protected] |
| From: Kavyasree, IT americas INC [email protected] Reply to: [email protected] Description: Performing quality control of SDTMs to ensure submission requirements are met. Create and be able to perform quality control of ADaMs to ensure submission requirements are met Responsible for the development and validation of ADaM data sets and analysis programs as per the study programming plan and statistical analysis plan. Plan, program and validate analysis datasets, statistical tables, listings and graphs in support of clinical study reports for all phases of the clinical endeavor in conjunction with biostatistician(s) and other SAS Programmer(s) Performing quality control of ISE/ISS datasets, tables, figures and listings with quality within the timeline. Communicating effectively internally with the project team members and externally with various vendors. Performing ad-hoc analyses for in-house request or QC of such analyses under tight timelines Participating in project team meetings to ensure timelines are met with high quality Leading effort in building in-house programming tools and macros Demonstrated practical understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry Professional Work Experience Requirements : Must have Bachelors in Biostatistics/Statistics or related field. Masters degree preferred. 5+ years of experience in the pharmaceutical, CRO or biotech industry. 4+ years of SAS programming experience in clinical trials with minimal 1 year of experience in oncology Extensive experience with CDISC standards Ideal candidate is someone can work independently with minimal supervision & highly productive; Has prior submission experience; Excellent technical skills in statistical programming, with advanced knowledge in SAS, and other statistical computing software. Ability to perform, coordinate and oversee the preparation, execution, reporting and documentation of all programming deliverables of a project, with minimal supervision. Excellent understanding of SOPs and industry regulations Keywords: active directory information technology |
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| Tue Aug 08 00:39:00 UTC 2023 |