JD of Principal Statistical Programmer
Responsibilities:
- Project lead level activities.
- Performs data analysis using primarily the SAS programming language for the summary
and interpretation of clinical trial data.
- Create CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic
Submission from the data received in non-standard form from various sources.
- Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and
graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
- Review Data Management Plan, Data validation plan and edit check specifications
- Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate
outputs according to the requirements.
- Implements and contributes to statistical analysis plans; provides additional expertise in
the analysis of clinical trial as it relates to protocol development, case report form design
and data collection.
- Recognizes inconsistencies and initiates resolution of data problems.
- Exercises independent judgment in developing methods, techniques and evaluation
criteria for obtaining results.
- Works on significant and unique issues where analysis of situations or data requires
evaluation of intangibles.
- Acts independently to determine methods and procedures on new assignments.
- May provide guidance to other lower level personnel.
- Works closely with Biostatistics to create analysis files specifications following the
instructions provided in Statistical Analysis Plan (SAP)
- Develop SAS coding and table templates for preparing, processing and analyzing clinical
data.
- Create/acquire tools to improve programming efficiency or quality.
- Establish monitoring of data transfers for ongoing trials to identify study conduct or data
quality issues.
- Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
Experience:
- Minimum 8 years Pharmaceutical/Biotech programming experience.
- NDA submission experience and knowledge required.
- Strong SAS programming and Statistical background along with experience with SAS Base,
SAS/Macros, SAS/Graph and SAS/Stat.
- Education Requirements (degree, certifications, etc.): Include must have and preferred
BS/MS in Statistics, Math or Scientific Discipline.
Work Location: Onsite in San Francisco Bay Area, CA