Job Description:-
● Good knowledge of clinical trials and clinical terminology. Proficient in understanding of Study Protocol, and CRF-Annotation (Case report Form)
Having Excellent knowledge in SAS/BASE, SAS/MACROS, SAS/SQL and SAS/ODS (RTF, PDF, HTML) procedures.
Good knowledge on CDISC- SDTM standards.Comprehensive prepared reports using SAS report generating procedures like PROC PRINT, PROC MEANS, PROC REPORT, PROC FREQ and PROC TRANSPOSE.
Good knowledge in SAS Base Procedures for Data Processing like FORMAT, SORT, TRANSPOSE and SQL
Data management skills like Merging, Handling missing values, Reading raw data files, Handling programming errors.
● Excellent knowledge in SAS FUNCTIONS and SAS FORMATS/INFORMATS.
● Thoroughly understand trial related documents such as Protocol and CRF.Extracting Data from Excel Sheet to SAS Datasets using PROC IMPORT procedure , Develop statistical analysis plans, including table, listing and graph specifications.
Specify the general structure of the analysis database, provide programming support for its development and validation.
Produce statistical analyses and statistical appendices, with appropriate documentation.
Validate statistical analyses and statistical appendices, with appropriate documentation.
Prepare Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy and other documents, as required. Contribute statistical methods section for Integrated Clinical Statistical Reports. Review Integrated Clinical Statistical Reports.
Qualification:-
Any life science student or related field and at least 5 years of programming in clinical research or related experience OR equivalent plus 3 years of programming in clinical research or related experience.
Must have SDTM, Tables & Listing, Adams experience required
Knowledge, Skills and Abilities:-
Skills: Base SAS, CDISC, SDTM,ADAM, TLF
Proficient in one or more programming languages.
Ability to train and mentor others.
Understanding of relational database structure and experience working with complex data systems.
Demonstrated strong attention to detail.
Excellent problem solving and innovative skills.
Good written and verbal communication skills.
Ability to independently and effectively organize and manage multiple assignments with challenging timelines.
Ability to adapt and adjust to changing priorities.
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