Senior Statistical Data Specialist

7 days ago

agra, India beBeeStatistical Full time

Job Overview Principal Statistical Programmer - Embed with Our Pharmaceutical Client to Drive Innovation. In this exciting role, you will be part of a new program and work closely with our client’s team to deliver high-quality statistical programming results. Your expertise in generating datasets, developing SAS programs, and maintaining quality control will drive success in our client's clinical development programs. Key Responsibilities: Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies. Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics) and complex graphs. Deliver high-quality statistical programming results including developing, validating and maintaining SAS and/or R programs tailored to clinical development programs’ needs. Participate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet pre-specified timelines. Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses. Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions. Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros. Participate in the development of CRFs, edit check specifications, and data validation plans. Provide review and/or author data transfer specifications for external vendor data. Collaborate with internal and external functions (e.g., software vendors, clinical development partners) to ensure meeting project timelines and goals. Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices.

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