We are hiring a Statistical Programmer Consultant on a contract basis. This position is remote.
The consultant will work with the Biometrics staff to provide programming support for Phase 1 to Phase 3 studies, including project integration and disease monitoring project work. Provide timely support to the project team on all statistical programming matters according to the project strategy. Program SDTM/ADaM/TLFs for the studies, write datasets specification, QC datasets and tables. Identify and communicate changes in project requirements that may affect key deliverables.
Responsibilities
· Involved in the progr a mming activiti e s on multiple p r ojects/ s tudies across variou s therapeutic areas, b oth internally and e x ternally b y CROs
· Creates and reviews annotated CRF to SDTM datasets
· Provides support in balancing conflicting priori t ies, promoting communication and adequate information flow to motivate , encoura g e and al i gn people with the company' s strategic objective s
· Functions as a positiv e role model for setting high e x pectations for quality, creativity and project ownership
· Works collaborative l y with Clinical Operations , Clinical Dat a Mana g ement, Global Drug Safety , Regulatory and Project Management management/staff to meet project deliverables and timelines for s t at istical data analysis and r ep o r t ing
· Provides technical input into documents produced by other functions (e.g., biostatisticians, d a t a managers , medical writ e rs)
· Works with Biometri c s and other functions for t h e de velopment and maintenanc e of the data review and r e porting tools, and any oth er s ta tistical applications as appropriate
· Involved with the strategy for process impro v em e nt
· Identifies new tool s to increase efficiency and quality
Requirements:
· 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
