ApicalGo Consultancy
Location
India | India
Job description
PRIMARY PURPOSE :The Lead Clinical SAS Programmer designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data, recognizes inconsistencies and initiates resolution of data problems. The Clinical Programmer typically creates programs using SAS to support the clinical research projects.RESPONSIBILITIES :- Collaborate with statistician and other functions to plan clinical programming deliverables such as data cleaning, extraction and integration programs, web reporting programs, integrity reports, analysis datasets, CDISC SDTM and ADaM data mappings, CSR tables, listings and figures (TLF), ad hoc reports, etc.- Develop prog provide critical review of SAP, mock shells. Review of Randomization plan, analysis data specification and another document within capacity of clinical programming ams for all such deliverables.- Develop and/or review programming specifications for various types of deliverables by applying SAS programming.- Contribute to the development of Data Management and Validation Plan, Statistical Analysis Plan, Table shells and other related documents within the capacity of clinical programming.- Perform all other project and process-related activities assigned by the supervisor, such as documentation of deliverables, timelines, client communication, etc.- Contribute to on-going data quality improvement efforts within assigned projects using SAS and other proprietary software.- Demonstrates judgment in resolving problems.- Maintain quality and timeliness of assigned project activities and perform control checks with help of other team members for all the generated reports.- Work with the programming teams and projects to ensure timeliness and quality of deliverables.- Significantly contribute in implementing process improvement programs.- Provide data on productivity, quality and timelines regularly to supervisor. - Adheres to corporate standards for documentation and validation of statistical programming. - Provides accurate, effective and timely communication of clinical study and statistical output to internal & external stakeholders.EXPERIENCE :- Requires a Master's Degree/Bachelor's Degree in Mathematics, Statistics, Engineering, Computer Science/Applications, Pharmacy, or any other similar type of qualification- At least six years (Lead)/Four years (Senior) of Clinical SAS programmer experience in Pharmaceutical/CRO- Good knowledge of programming languages (SAS Macros, SQL, STATS, graph and ODS) with an understanding of databases.- Knowledge of CDISC SDTM and ADaM models and data mapping process is desirable.- Good analytical skills with the ability to process scientific and medical data.- Knowledge of regulatory submission process- Knowledge in development, documentation, and testing of analysis data and programming code to meet regulatory and company standards.- Understanding of GCP principles and other regulatory standards in Clinical Research.- Good organizational and communication (written and oral) skills, ability to manage multiple tasks, ability to work with minimum supervision, as well as in a team environment and a desire to improve skills (ref:hirist.tech)
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