Associate Director, Biostatistical Programming

What you will do

Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As an Associate Director of Biostatistical Programming (Programming Execution Lead), you will partner with Global Programming Leads (GPL) and lead a large offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to successfully execute end-to-end programming activities for all studies and global regulatory approval submissions for large, high priority products or indications across products. Together with GPL, this Associate Director will be accountable and responsible for Global Statistical Programming study results and submission activities for the assigned products or indications across products.

The Associate Director of Biostatistical Programming will contribute at the department level by leading major GSP technical or operational efficiency initiatives and ensuring compliance with R&D standards, leading or serving as a member of GSP and cross functional consultancy groups such as Submission Consultancy Group and ADaM Consultancy Group.

The Associate Director will drive the piloting and integration of new technologies, including artificial intelligence, statistical programming automation tools, and open-source platforms to improve quality and efficiency across the organization.

Key Responsibilities:

• Accountable and responsible for ensuring successful execution and delivery of GSP milestone analysis deliverables and regulatory submission packages for a group of high priority and/or high complexity Amgen products being supported by the offshore programming team.
• Work with GPL to ensure successful implementation of programming strategies such as functional standards and industry requirements for the assigned products globally.
• Plan and monitor progress of projects and address issues accordingly.
• Provide GSP product level input to developing and managing resource plans and budgets for GSP.
• Efficiently and effectively monitor and utilize assigned staff at product level according to priorities.
• Drive the piloting and integration of new technologies, including artificial intelligence, statistical automation tools, and open-source platforms to improve functional maturity and efficiency.
• Lead and/or participate in departmental process improvement initiatives and cross-functional working groups.
• Represent GSP in study and system audits and inspections by internal and external bodies.
• Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally.
• Provide hands-on support to the assigned product areas as required.
• Provide coaching and mentoring to GSP staff globally.
• Provide input into career development plans to direct reports and staff on assigned projects

This position will be located at Amgen India (Hyderabad).

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, computer science, or other related quantitative or scientific subjects, with at least 10 years of statistical programming experience in clinical development environment.
• Strong technical, communication, and leadership skills
• Ability to lead and manage a large team of programmers in successful and timely completion of all programming activities for highly complex studies and regulatory submissions
• Experience developing a successful offshore statistical programming team
• Flexibility and desire to work across different time-zones
• Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, and others) or R
• Prior regulatory submission experience for approval
• Thorough understanding and experience with data quality and compliance checks
• Experience working effectively in a globally dispersed team environment with cross-cultural partners
• Prior staff development leadership and project management experience
• Excellent oral and written English communication skills
• Ability to effectively perform complex statistical programming and related tasks

Preferred Skills:

• MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
• Familiarity with open-source programming tools (e.g., R, Python), automation platforms, and emerging technologies in statistical programming.