Statistical Programmer Consultant (REMOTE)

The Steely Group

Cambridge, MA, USA

Published: 6/14/2022

Technology

Full Time

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 tasks

Company DescriptionThe 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.

Company 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.