Senior Director of Statistical Programming, Statistical Programming

Amgen

Hyderabad

On-site

INR 600,000 - 1,200,000

Full time

12 days ago

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Job summary

Amgen India (Hyderabad) seeks a Senior Director of Global Statistical Programming to provide local leadership for its international clinical development programs. The role oversees strategic and operational programming delivery, builds a center of excellence, and drives standardization and AI-enabled automation across studies.

You will collaborate with Biostatistics, Data Management, and Regulatory Writing to ensure timely, compliant deliverables and contribute to global initiatives in digital

Qualifications

  • BA/BSc or higher in biostatistics, statistics, mathematics, or related quantitative or scientific subjects.
  • 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.

Responsibilities

  • Provide strategic and operational leadership for statistical programming delivery within Amgen's 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 Amgen's 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).

Skills

Leadership
Cross-functional collaboration
Communication
Team management
Digital transformation

Education

BA/BSc or higher in biostatistics or related
MSc or higher in biostatistics or related

Tools

SAS
CDISC standards
R
Python
Automation platforms

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 together researching, 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.

Amgen is expanding its global Statistical Programming capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As Sr. Director of Statistical Programming, you will provide local functional leadership from AIN, supporting global clinical development programs in close partnership with global teams through seamless execution that leverages digital innovation to drive quality deliverables, operational excellence, and regulatory compliance.

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).
What we expect of you

We are all different, yet we all use 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
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.
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