Sr. Director, Statistical Programming

Amgen; India; On-site; INR 6,000,000 - 12,000,000; Full time

Job summary

Amgen India in Hyderabad seeks a Senior Director of Global Statistical Programming to lead strategic and operational programming efforts across the global framework. You will shape programming standards, grow a high-performing team, and drive scalable models for faster, compliant regulatory submissions.

The role requires deep expertise in biostatistics, SAS/CDISC, and collaboration across Biostatistics, Data Management, and Regulatory Writing.

Qualifications

• BA/BSc or higher in biostatistics, statistics, mathematics, or related quantitative field.
• MSc or higher in biostatistics, statistics, mathematics, or related field.
• Extensive experience with SAS and CDISC standards, and with global regulatory submissions.
• Experience managing large teams to complete end-to-end statistical programming activities from study start-up to regulatory submissions.
• Familiarity with open-source tools (R, Python), automation platforms, and emerging technologies in statistical programming; experience with AI/workflows in GxP.
• Strong cross-functional collaboration and leadership in a global matrix structure.

Responsibilities

• Provide strategic and operational leadership for statistical programming delivery within Amgen's global framework, site accountability in AIN.
• Oversee execution of statistical programming activities in AIN for quality, timeliness, compliance, and inspection readiness.
• Build a center of programming excellence at AIN, including hiring, onboarding, mentoring, and performance management.
• Lead implementation of reusable code frameworks, standardized processes, and scalable programming models to improve quality and efficiency.
• Collaborate with Biostatistics, Data Management, and Regulatory Writing to align deliverables with timelines.
• Pilot and integrate new technologies, including AI, automation tools, and open-source platforms to improve quality and efficiency.
• Contribute to global initiatives in statistical process improvement, digital innovation, and analytics capability building.

Skills

Biostatistics background

Leadership

Cross-functional collaboration

Regulatory submissions

Education

BA/BSc or higher in biostatistics/related

MSc or higher in biostatistics/related

Tools

SAS

CDISC standards

R

Python

Automation platforms

Agentic AI in GxP

Job description

Career CategoryClinical DevelopmentJob DescriptionHOW MIGHT YOU DEFY IMAGINATION If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Senior Director Global Statistical Programming

What you will do

Lets do this. Lets change the world.

Responsibilities

• Provide strategic and operational leadership for statistical programming delivery within Amgens global framework, with site accountability based in AIN.
• Oversee the execution of statistical programming activities in AIN, ensuring quality, timeliness, compliance, and inspection readiness.
• Shape and grow a center of programming excellence at AIN, aligned with Amgens global delivery model and standards, including hiring, onboarding, mentoring, and performance management.
• Lead the implementation of reusable code frameworks, standardized processes, and scalable programming models to drive quality, speed, and consistency.
• Collaborate cross-functionally with Biostatistics, Data Management, and Regulatory Writing to align programming deliverables with strategic timelines.
• Champion the piloting and integration of new technologies, including artificial intelligence, statistical programming automation tools, and open-source platforms to improve quality and efficiency.
• Contribute to global initiatives in statistical process improvement, digital innovation, and analytics capability building.

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, or other related quantitative or scientificsubjects

Preferred Skills

• MSc or higher degree in biostatistics, statistics, mathematics, or related quantitative or scientific subjects
• Extensive experience with SAS and CDISC standards, and with global regulatory submissions
• Demonstrated success managing large teams to complete end to end statistical programming activities from study start up to regulatory submissions
• Familiarity with open-source programming tools (e.g. R, Python), automation platforms, and emerging technologies in statistical programming
• Experience applying or managing Agentic AI or automated workflows within a GxP environment
• Proven ability to drive process innovation, implement standardization strategies, and deliver high-quality outputs across studies
• Strong cross-functional collaboration skills and ability to work in a global matrix structure
• Excellent communication and leadership skills, with the ability to influence at multiple levels of the organization
• Thrive

Thrive

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

What you can expect of us

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.