Biostatistical Programming Associate

Overview

Biostatistical Programming Associate performing hands-on statistical programming to support analysis of phase 1 to 4 clinical studies and regulatory submissions.

What you'll do

• Analyze and report clinical trial data using SAS and/or R.
• Create and validate SDTM, ADaM, and other analysis datasets for safety and efficacy.
• Create and validate tables, listings, and figures for safety and efficacy.
• Maintain tracking and validation documentation.
• Collaborate cross-functionally to create and/or validate data quality checking programs.
• Interact with global study team members from other functions.

What you'll need

• At least 3 years of statistical programming experience in a clinical development environment.
• BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or related quantitative/scientific subjects.
• Ability to manipulate, analyze, and report clinical trial data.
• Working knowledge of latest CDISC SDTM standards and familiarity with CDISC ADaM and Define standards and implementation.
• Familiarity with data quality and compliance check tools.
• Ability to deliver quality outputs within challenging timelines.
• Excellent oral and written English communication skills.

Nice to have

• MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative/scientific subjects.
• Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming.
• In-depth knowledge of SAS/STAT packages.
• Prior regulatory submission experience.

Details

• Location: Amgen India (Hyderabad).