Full Job Description
The Statistical Programmer is an integral project team member in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data under the direction and oversight of a Senior Statistical Analyst. The Statistical Programmer interfaces with key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations.)
Responsibilities
- The Statistical Programmer will:
- Create documentation for regulatory filings including reviewers guides and data definition documents.
- Participate in the development of standard SAS Macros.
- The Programmer will:
- Consolidate heterogeneous data sources (e.g. clinical study databases, external databases, real-world data) to prepare analysis-ready data sets within a defined quality control process supporting a particular study.
- Perform exploratory data analyses and visualizations in interaction with the clinical pharmacologist or pharmacometrician.
- Produce dynamic and static data visualizations to communicate quantitative analyses.
- Develop SAS programs for the creation of ADaM data sets following CDISC standards
- Develop SAS programs for the creation of Tables, Listings and Figures.
- Validation of ADaM data sets.
- Validation of Tables, Listings and Figures.
- Create specifications for the structure of ADaM data sets for individual studies.
Qualifications
Minimum Qualifications:
- MS in Statistics, Computer Science or a related field with 0+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 2+ years of relevant experience.
- Demonstrated practical understanding of SAS programming and experience with pharmacokinetic (PK) analysis and reporting.
- Ability to communicate clearly both oral and written.
Preferred Qualifications
- Pharma experience
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
