Biostatistical Programming Mgr
$90,000–$120,000 year
On-site · Hyderabad, Telangana, India
Job Summary
As a Biostatistical Programming Manager at Amgen, you will serve as the Study Lead Programmer for multiple studies, responsible for setting programming strategies, ensuring compliance and quality of all deliverables, and leading the programming team. This role involves significant hands-on statistical programming, programming specification creation, and participation in cross-functional study start-up activities. Candidates must possess a BA/BSc in a related field and have at least 6 years of experience in statistical programming, with a strong understanding of clinical trial processes and CDISC standards. Preferred qualifications include an MSc degree, familiarity with programming tools, and prior regulatory submission experience.
Required Qualifications
- BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects
- At least 6 years of statistical programming experience in clinical development environment
- Thorough understanding of clinical trial processes, from data collection to analysis reporting
- Proven record of superior statistical programming and problem-solving skills within clinical development environment
- Prior experience and ability to lead and manage statistical programmers
- In-depth knowledge on CDISC SDTM, ADaM, and Define standards
- Advanced analysis and reporting skills in SAS
- Experience in data quality and compliance check tools
- Excellent project management skills
- Excellent oral and written English communication skills
- Ability to work effectively in a globally dispersed team environment
- Willingness to provide guidance to team members on technical and process questions
Desired Qualifications
- MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
- Familiarity with open-source programming tools (R, Python)
- Experience with automation platforms and emerging technologies in statistical programming
- Prior regulatory submission experience for drug approval
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.