Statistical Programmer

Katalyst CRO; Atlanta (GA); On-site; USD 75,000 - 100,000; Part time

Job summary

A clinical research organization in Atlanta is seeking a mid-senior Statistical Programmer with extensive SAS programming experience. The role involves preparing SDTM and ADaM datasets and conducting quality assurance for clinical trials. Candidates should have strong statistical knowledge and a minimum of 6 years in drug development projects. This position offers a contract employment type with opportunities to work on diverse client projects.

Qualifications

• Minimum 6 years of SAS programming and analysis experience in drug development.
• Experience with generating define.xml and related documentation.
• Ability to conduct quality control and assurance on datasets.

Responsibilities

• Prepare SDTM and ADaM datasets, Tables, Listings, & Figures for clinical trials.
• Conduct quality control and assurance activities.
• Support client projects across various therapeutic areas.

Skills

Advanced SAS macro programming

Clinical trials experience

Pinnacle21 validation process

CDISC standards implementation

Statistical analysis proficiency

Good communication skills in English

Team work

Attention to detail

Education

B.Sc., M.Sc. in Biostatistics/Statistics or related fields

Job description

Statistical Programmer

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Requirements

• B.Sc., M.Sc., or equivalent education in Biostatistics/Statistics, Bioinformatics, Life Sciences, Mathematics, Physical Sciences, or related fields
• Advanced SAS macro programming experience is required for the development of global tools that will increase the efficiency and capacity of the Statistical Programming group
• At least 6 years of Clinical trials related work experience in SAS programming, analysis and reporting in the context of drug development projects is required
• Well experienced in Pinnacle21 validation process, generating define xml using Pinnacle 21
• Extensive experience in implementing CDISC standards, as well as annotating CRFs, creating specifications for SDTM and ADaM datasets
• Experienced in creating Define.xml and the corresponding Reviewers' Guide for SDTM and ADaM datasets
• Good verbal and written communications skills in English
• Demonstrated knowledge of clinical drug development
• Proficiency in conducting advanced statistical analyses
• Must be independent, attention to detail, accountable to quality and timely delivery
• Ability to work on multiple collaborative projects, team player mentality

Responsibilities

• As a Statistical Programming Consultant, you will use your SAS and R programming skills to prepare SDTM and ADaM datasets, Tables, Listings, & Figures (TLFs), as well as create related documents such as aCRF, programming specifications, and define packages (including reviewer's guides) for Phase 1 to Phase 4 clinical trials
• In addition, you will conduct quality control and quality assurance activities on datasets and outputs and may participate in company initiatives to improve the efficiency of end-to-end statistical programming activities, analysis, and reporting (IT, methodology, automation, quality)
• You will work closely in teams led by statistical programmers, statisticians, and drug development consultants, supporting a variety of client projects across various therapeutic areas and complexities

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Information Technology
• Pharmaceutical Manufacturing