Key Responsibilities:
Analysis and reporting of clinical trial data using SAS and/or R
Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy
Creation and validation of complex tables, listings, and figures, both safety and efficacy
Prepare statistical programming specifications
Prepare statistical programming related documents for regulatory submissions
Maintain tracking and validation documentation
Collaborate with cross-functional team and create and/or validate complex programs for checking data quality
Interact and collaborate with study team members from other functions globally
Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP
This position will be located at Amgen India (Hyderabad).
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation.
Basic Qualifications:
BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects,
with at least 4 years of statistical programming experience in relevant career statistical programming experience in a clinical development setting.
Familiarity with drug development life cycle and excellent skills with the manipulation, analysis and reporting of complex clinical trial data
Ability to effectively perform complex statistical programming and related tasks
Ability to provide quality output and deliverables in adherence with challenging timelines
Ability to work effectively on multiple tasks or projects across therapeutic areas
Ability to work effectively and successfully in a globally dispersed team setting with cross-cultural partners
Working knowledge of latest CDISC SDTM standards and familiar with CDISC ADaM and Define standards with solid ability to implement the standards
In depth knowledge of SAS/STAT packages
Familiar with data quality and compliance check tools
Excellent oral and written English communication skills
Preferred Skills:
MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming
Prior regulatory submission experience for drug approval