The consultant will provide programming/analytical support utilizing client as the primary programming language to create and manage the production of analysis reports.
summary tables/listings and graphs for clinical trials submitted to various regulatory bodies worldwide.
The consultant must have excellent communication skills and must be able to communicate about the techniques developed and results of analysis both to executives and other analysts in the organization.
Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/Client), utilizing SAS programming.
Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs).
Develop SAS programs and generate complete, accurate and validated statistical TLGs in well-defined formats.
Program SDTM and ADaM datasets according to the dataset specifications
Create SDTM annotated patient Case Report Forms.
Perform data conversion between datasets with two different formats according to conversion requirements/specifications, e.g., converting from Excel data records to client datasets, non-CDISC compliant datasets to CDISC compliant datasets.
Manage electronic data transfers from trial sponsors or other external clinical trial data vendors, such as central laboratories or other specialty laboratories.
Document data and programming information in accordance with Corporate Governing Documents (Policies, SOPs, or Work Instructions).
Archive clinical trial data (raw data, SDTM, and ADaM datasets) and programming documentation in accordance with Corporate Governing Documents and/or clinical trial sponsor's specific requirements.
Write SAS programs to produce tables, listings, and graphs for ad hoc requests, annual progress reports, integrated summaries, publications and other clinical research reports.
Collaborate with Biostatisticians, Clinical Research Associates, Medical Writers, Regulatory Affairs and Clinical Data Management teams to gather specifications for informative tables, listings and graphs.
Build client data sets from various data sources which meet provided specifications.
Execute edit/logic checks to assist in data cleaning.
Maintain and execute programs for the evaluation and validation of incoming clinical data.
Perform validation of the analysis data sets, tables, listings and graphs.
Utilize macro libraries and complex data step techniques to standardize programming.
Maintain and enhance existing programs for clinical studies.
Gather and analyze programming requirements to develop clinical trial reporting systems.
Maintain detailed design specifications.
Ensure that programs and reports follow departmental/company standard operating procedures.
Assist in the development of departmental systems and generate/maintain systems documentation.
Participate in the preparation of clinical and statistical summary reports.
Requirements:
Bachelor's degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
Healthcare or technology related field.
6+ years of SAS programming experience working with clinical trials data in the Pharmaceutical & Biotech industry.
Be proficient in Base SAS programming (DATA step), SQL programming (i.e., use of SQL pass-through or PROC SQL), as well as the SAS Macro language for use in making code more efficient.
Familiarity with programming to generate summary statistics (mean, median, etc.) and complex statistical methods (i.e., SAS GLM, Logistic regression, and survival analysis).
CDISC data models a necessity, especially SDTM then ADaM.
SDTM and ADaM dataset experience.
Good written and spoken communications skills in English and thought-leadership skills.
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