Company Name:-
Cytel, India

Job Location:-
India

Job Summary:-
Working under the direction of a Senior Statistical Programmer or a team Lead, the Statistical programmer conducts statistical programming activities for the reporting of clinical study data.

Develops and supports statistical programming computer systems that are used in the production of statistical analysis plan (SAP)-planned tables, data listings, and graphs, integrated summaries of safety and efficacy, ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, programs, programming table of contents, and patient profiles.

Essential functions include:
Creating systems that assist the biostatistical programming staff and biostatistical staff to create tables, data listings, graphs, and analysis for final reports, abstracts, posters, manuscripts, and other clinical publications
Developing systems to support electronic regulatory submissions
Providing systems and support for clinical data management staff, statistical programmers, quality control (QC) staff, and biostatisticians
Producing and supporting systems that extract data from the clinical database
Building analysis databases composed of SAS datasets.

Perform all the above tasks using standard operating procedures (SOPs) as defined in Quality Management System or the respective client(s) as applicable
The Statistical programmer must follow established standardized design and programming procedures; develop, enhance, evaluate, and validate standardized macros and utility programs; and ensure that regulatory requirements are met through validation/compliance activities.

Qualifications and Experience:
Minimum Education: BS or MS degree in Computer Science, Statistics, or related health science field with a minimum of 3 year of SAS programming experience with clinical trial data.

Minimum Work Requirements: General knowledge of regulatory requirements and drug development process.

Skills: Excellent organizational skills and good verbal and written communication skills.

Ability to work independently is required.

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