Principal Statistical Programmer (Hyderabad)

Principal Statistical Programmer (Hyderabad)

06 Aug
|
SDC (Statistics & Data
|
Hyderabad

06 Aug

SDC (Statistics & Data

Hyderabad

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Summary

Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creations/transfers, integrity checks, and quality audits. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis.

Primary Responsibilities





Perform or oversee team in performing all statistical programming required for clinical trial analysis and reporting on large scale projects of high complexity
Apply appropriate statistical methods for data analysis and provide statistical programming expertise for project teams
Review the Statistical Analysis Plan in preparation for programming the planned analyses
Lead design/development of SAS macros and other utilities to expedite SAS programming activities
Organize and conduct internal training sessions and author papers for conferences
Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request
Participate in statistical program validation and quality control activities
Develop or review SDTM aCRF and specifications, ADaM specifications; complete programming and validation of CDISC SDTM and ADaM datasets
Review pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines
Develop define.xml, study data reviewers guide and analysis datasets reviewer

📌 Principal Statistical Programmer (Hyderabad)
🏢 SDC (Statistics & Data
📍 Hyderabad

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