Statistical Programmer Consultant (REMOTE)

Job Description

Working with the Biometrics staff, the Statistical Programmer Consultant provides programming support for Phase 1 to Phase 3 studies, including project integration and disease monitoring project work.

Provides timely support to the project team on all statistical programming matters according to the project strategy. Programs SDTM/ADaM/TLFs for the studies, write datasets specification, QC datasets and tables. Identifies and communicates changes in project requirements that may affect key deliverables.

Responsibilities:

Involved in the programming activities on multiple projects/ studies across various therapeutic areas, both internally and externally by CROs

Creates and reviews annotated CRF to SDTM datasets

Provides support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company' s strategic objectives

Functions as a positive role model for setting high expectations for quality, creativity and project ownership

Works collaboratively with Clinical Operations, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting

Provides technical input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers)

Works with Biometrics and other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate

Involved with the strategy for process improvement

Identifies new tools to increase efficiency and quality

Requirements / Qualifications:

Master's Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline

Minimum of 1-5 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry

Advanced SAS programming skill s and experience in other statistical software, such as R and S-Plus

Experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies

Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regards to statistical programming processes, management of statistical programing projects

Excellent organizational skills and ability to prioritize tasksCompany Description

The Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.

Fully remote