Sr. Statistical Programmer
455 Mission Bay Blvd. (South) San Francisco, CA 94158
Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients.
- Provide strong technical statistical programming to Statistical Programming function within Biometrics.
- Provide expertise and hands on support to clinical projects across multiple therapeutics areas.
- Responsible for processing of clinical data required for analysis of clinical trials for Phase 1-4.
- Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
- Generate and QC summary tables, data listings and graphs for in-house analyses of study data or publications using SAS standard coding practices.
- Create/review programming plan, specifications for datasets and TLFs.
- Familiar with CDISC conventions, i.e., SDTM and ADaM models and hands on experience in implementing these models.
- Validate work of other programmer/analysts at CRO or in-house.
- Provide guidelines, review, and QC CRO deliverables to ensure the quality of deliverables.
- A minimum 8 years relevant career experience in the pharmaceutical or biotechnology industry.
- Experience in Oncology and or CNS therapeutic areas preferred.
- Experience in ISS, NDA/BLA submission and understanding of regulatory requirements preferred.
- Very good knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment in particular clinical trial data setting.
- Strong understanding of clinical trial data and hands on in data manipulations, analysis and reporting of analysis results.
- Thorough understanding of relational database components and theory.
- Excellent oral and written communication skills.
- A minimum of a Bachelor's degree in Computer Science, Mathematics, Statistics, and related areas is required.
- Equivalent experience may be accepted.