Previous Job
Statistical Programmer
Ref No.: 18-12596
Location: Waltham, Massachusetts
Start Date / End Date: 10/01/2018 to 09/30/2019
The Statistical Programming Contractor supports statistical programming activities in the production of the analysis datasets, tables, listings, figures, electronic submission components, and complex ad hoc analyses.

Key Responsibilities:
- Does both production and QC programming of SDTM datasets, analysis datasets, tables, listings, and figures, for multiple clinical trials using SAS software.
- Ensures standards at a drug program level; integrates data across multiple studies or drug programs.
- Works with minimal supervision under the direction of a lead programmer.
- Communicates issues to lead programmer or manager.
- Must meet timelines or communicate proactively and effectively if timelines are at risk so that plans can be adjusted.
- Expected to contribute to departmental process improvement initiatives.

Essential Skills and Qualifications Required
- Must have strong time management and communication skills.
- Able to handle a moderate to large volume of complex tasks with minimal supervision.
- Able to handle ad-hoc requests with minimal guidance.
- Recognizes when negotiating skills are needed and seeks assistance when necessary.
- Excellent organizational, interpersonal, and communication skills.
- Previous SAS programming experience, including SAS STAT, GRAPH and MACRO.
- Previous relevant pharmaceutical/biotech industry experience.
- Extensive knowledge of drug development process and clinical trials.
- Extensive knowledge of drug submission requirements, relevant ICH and FDA/EMEA guidelines, CDISC standards.

Education and Experience Requirements
- Bachelor's degree or equivalent, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
- 3 to 10 years of pharmaceutical/biotech industry experience.
Skill Required / Desired Amount of Experience
SAS Programming Required 4 Years
Knowledge of drug development process and clinical trials Required 4 Years
Knowledge of drug submission requirements, relevant ICH and FDA/EMEA guidelines, CDISC standards. Required 4 Years
Linux/UNIX Required 4 Years