Biostatistics Programmer

USA-Remote
Full-Time
Part-Time
Internship
DESCRIPTION

The SAS 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.

Duties & Responsibilities

The SAS 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, clinical programmers, quality control (QC) staff, and biostatisticians; producing and supporting systems that extract data from the clinical database; and building analysis databases composed of SAS datasets. The SAS 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.

The Statistical Programmer may work on proprietary or Client's systems and under the Client's SOPs/processes.

REQUIRED Experience

At least 3 years experience in sponsor, clinical or CRO environment.

Working knowledge of clinical research industry and requirements for MedTech and/or BioTech industries.

Working knowledge of Good Clinical Practice (GCP) or applicable regional regulations and guidance.

preferred Experience

Minimum Education: BS or MS degree in Computer Science, Statistics, or related health science field with a minimum of 1 year of SAS programming experience with clinical trial data.

REQUIRED SKILLS

Minimum Work Requirements : General knowledge of regulatory requirements for medical device and/or drug development process .

Skills: Excellent organizational skills and good verbal and written communication skills. Ability to work independently is required.

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