Senior Stats Programmer (VAX)
On-siteHyderabad, Telangana, India
Job Summary
Perform programming activities for statistical deliverables including SDTM, ADaM, Tables Listings and Figures (TLF) across various analyses and projects. Review study documents such as protocols, Case Report Forms, and Statistical Analysis Plans, then provide specifications for CDISC data packages to ensure compliance with Health Authorities. Execute quality control for deliverables, create core integrated clinical databases by pooling datasets, and draft specifications for multi-study data pooling. Independently create specifications and perform exploratory or post-hoc analyses while maintaining adherence to SOPs and guidelines.
Required Qualifications
- 5-7 years' experience in statistical programming clinical research
- some Vaccines experience (designs, endpoints, statistical methods, ...)
- SAS (>3 years): excellent technical skills in BASE, STAT, MACRO, GRAPH, SQL, R
- familiar in statistical programming
- Experience programming CDISC SDTM/ADaM datasets
- vaccines specifics (including writing specifications, P21, proficiency with controlled terminology, value-level metadata, analysis results metadata, define.xml, Reviewers Guide)
- Experience pooling data from multiple studies according to existing specifications
- Experience planning and drafting specifications for pooling data from multiple studies
- Ability to independently create specifications
- Knowledge of descriptive statistics
- Good understanding of processes associated with clinical trials
- Demonstrate interpersonal skills necessary for effective teamwork
- Demonstrate ability to organize multiple work assignments and establish priorities
- Demonstrate critical thinking skills beyond simply following directions or specifications
- Bachelors or Masters degree in Statistics, Mathematics, Computer Science or related health sciences or equivalent experience
- English: Highly effective communication, both oral and written
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