Senior Director , Biostatistics

What you will do

Lets do this. Lets change the world.

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. As Senior Director Biostatistics, you will lead the India-based Biostatistics team; delivering statistical strategy, operational excellence, and digital innovation aligned with our global Clinical Development strategy. This role provides local functional leadership that contributes to global clinical development through seamless execution that leverages digital innovation capabilities.

Responsibilities:

• Lead strategic statistical direction for a portfolio of development programs, aligning with Global Statistical Strategic Plans (GSSPs) and Evidence Generation Plans (EGPs) and influencing global product development decisions.

• Serve as the primary point of contact for statistical oversight in India; partner with global stakeholders in R&D, regulatory, HEOR, and clinical teams.

• Oversee operational delivery of statistical activities, ensuring Inspectionreadiness, data quality, and compliance with regulatory standards.

• Shape a center of biostatistics excellence at AIN, aligned with Amgens global standards and operating model, including hiring, onboarding, mentoring, and performance management.

• Provide governance and oversight of vendor and FSP partnerships, ensuring alignment with performance standards, delivery quality, and operational risk mitigation.

• Champion the piloting and integration of new technologies, including artificial intelligence, statistical automation tools, and open-source platforms.

• Contribute to global initiatives in statistical process improvement, digital innovation, and analytics capability building, and represent Amgens Biostatistics function in scientific and/or industry forums where applicable.

This position is currently locatedat 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 strategic Biostatisticsleader with a passion for tech-enabled transformation.

Basic Qualifications:

• Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research withat least 12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research

• Masters degree in Statistics/Biostatistics or related subject with high statistical content withat least 15+ years of post-graduate statistical experience in the pharmaceutical industry or medical research

Preferred Skills:

• Doctorate in Statistics/Biostatistics with12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research

• Masters degree in Statistics/Biostatistics with15+ years of Biostatistics experiencein the pharmaceutical industry or medical research

• Experience with global regulatory submissions and HTA/payer collaborations

• Leadership in building, managing, and mentoring globally distributed teams

• Proven success in cross-functional stakeholder alignment

• Strong analytical, problem-solving, and technical communication skills

• Experience applying or managing AI/ML solutions, including familiarity with R, Python, and automated statistical tools

• Exposure to cloud platforms or data lakes is a plus