Senior Manager, Biostatistical Programming

Amgen Technology; Hyderabad; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Amgen India in Hyderabad is seeking a Senior Manager of Biostatistical Programming to lead an offshore team and ensure end-to-end programming for products across therapeutic areas. You will partner with the Global Programming Lead to deliver milestone analyses and regulatory submission packages, while guiding the strategy, resources, and quality of programming efforts.

We expect a seasoned leader with extensive SAS programming experience, strong communication skills, and a proven track record in

Qualifications

• 8+ years of statistical programming experience in clinical development.
• Experience leading offshore programming teams.
• Regulatory submission experience for drug approval.

Responsibilities

• Lead offshore team of Study Lead Programmers and Study Programmers for end-to-end programming.
• Deliver milestone analysis deliverables and regulatory submission packages.
• Plan and monitor project progress and manage resources and budgets.
• Provide coaching and mentorship to staff and contribute to career development.
• Develop, review and implement policies, SOPs and other controlled documents.

Skills

Leadership

Communication

Statistical programming

offshore team leadership

Education

BA/BSc or higher in biostatistics or related

MSc or higher in statistics/biostatistics

Tools

SAS (SAS/STAT, Macro, Graph, SQL)

R

Python

Job description

Senior Manager, Biostatistical Programming

HOW MIGHT YOU DEFY IMAGINATION

Join us.

Senior Manager, Biostatistical Programming

What you will do

Lets do this. Lets change the world.

Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Senior Manager of Biostatistical Programming (Programming Execution Lead), you will partner with the Global Programming Lead (GPL) and lead an offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to ensure successful execution of end-to-end programming activities for products within or across therapeutic areas. Together with the GPL, this Senior Manager will be accountable and responsible for Global Statistical Programming study results and drug approval submission activities for the assigned product areas.

Key Responsibilities:

• Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for a product, or group of 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 product 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.
• Lead and/or participate in departmental process improvement initiatives and cross-functional working groups.
• Assist 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 local programming staff.
• Provide input into career development plans for all staff on assigned projects

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, computer science, or other related quantitative or scientific subjects, with at least 8 years of statistical programming experience in clinical development environment.
• Strong technical, communication, and leadership skills
• Ability to lead and manage programmers in successful and timely completion of all programming activities for a study or multiple studies from end to end
• 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, etc.)
• Prior regulatory submission experience for drug approval
• Thorough understanding and experience with data quality and compliance checks
• Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans)
• 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

Thrive

What you can expect of us

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.

• 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