Senior Statistical Programmer

Job Description:
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.

Required 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.