Submit Your Resume View All Jobs
Our client is looking for a Project Manager, Statistical Programming
Location: MA, USA
Work as a project lead/statistical programmer on drug development project teams. Support the inferential analysis of key safety and efficacy endpoints from clinical trials.
Primary responsibilities include the production of clinical trial deliverables (e.g. analysis datasets and specifications, well-documented SAS® code, summary tables, figures, listings and analyses) for internal projects in support of internal biostatisticians, as well as providing validation and review of key results for external projects.
Programming of ad hoc requests for exploratory analyses and time-sensitive deliverables. Develop global macro modules. Provide team leadership within the programming function. Manage projects and teams as needed. Must be able to work in a standardized programming environment and communicate results and work product both verbally and in writing.
Essential Functions Provide statistical programming representation on project teams. Support internal biostatisticians in the production of clinical trial report deliverables, including analysis datasets and summary report outputs. Provide validation and review services for internal and external projects. Write up and communicate findings, as necessary. Write computer programs in SAS for the production of clinical trial deliverables, and document the same, in a manner consistent with internal SOPs. Prepare electronic and paper deliverables for submission to FDA in a manner consistent with FDA Guidance practices. Interact with other project team members, as necessary. Interact with external vendor personnel, as necessary.Requirements:
Minimum education requirements: Bachelors
Experience required: 6+ Years
Knowledge & skills: 6+ years of pharmaceutical or biotech industry experience. SAS® experience is a requirement. Production of clinical study report deliverables, including analysis datasets, summary tables, figures and listings are relevant qualifications for this position. Demonstrated, strong experience with SAS/Graph and SAS/Stat products is highly desired.
Other requirements: Experience with regulatory submission, electronic submissions, and relational databases is desirable.
The individual in this position should have a demonstrated capability to deliver work product in a multi-project, team-oriented environment.Submit Your Resume View All Jobs