Sr. Statistical Programmer

• 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.

Skills:

• 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.

Education:

• A minimum of a Bachelor's degree in Computer Science, Mathematics, Statistics, and related areas is required.
• Equivalent experience may be accepted.