Biostatistical Programming Associate
On-siteHyderabad, Telangana, India
Job Summary
Perform hands-on statistical programming activities to support data analysis for phase 1 to 4 clinical studies and regulatory submissions. Conduct analysis and reporting of clinical trial data using SAS and/or R. Create and validate SDTM, ADaM, and other analysis datasets for both safety and efficacy. Maintain tracking and validation documentation while collaborating with cross-functional teams to create and validate programs for checking data quality. Interact with study team members globally to ensure adherence to CDISC standards and deliverables within challenging timelines. This role is based in Hyderabad, India, within Amgen's Global Statistical Programming capabilities.
Required Qualifications
- BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects
- at least 3 years of statistical programming experience in clinical development environment
- Familiarity with drug development life cycle
- Excellent skills with manipulation, analysis and reporting of clinical trials data
- Ability to provide quality output and deliverables, in adherence with challenging timelines
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
- Ability to work effectively on multiple tasks or projects
- Working knowledge of latest CDISC SDTM standards
- Familiar with CDISC ADaM and Define standards
- Ability to implement the standards
- Familiar with data quality and compliance check tools
- Excellent oral and written English communication skills
- This position will be located at Amgen India (Hyderabad)
Desired Qualifications
- MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
- Familiarity with open-source programming tools (R, Python)
- Familiarity with automation platforms
- Familiarity with emerging technologies in statistical programming
- In depth knowledge of SAS/STAT packages
- Prior regulatory submission experience
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