Amgen

Biotechnology

AssociateDirector,BiostatisticalProgramming

₹45–70L ~AI est. India FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Associate Director, Biostatistical Programming at Amgen. Skills: Biostatistical Programming, Clinical development, Regulatory submissions. Ensure successful execution analysis deliverables. Ensure successful execution regulatory submission packages”

What You'll Achieve.

Successful execution analysis deliverables; Successful execution submission packages; Improve quality; Improve efficiency

Industry & Context.

Biotechnology

What They're Looking For.

Must Have

BASc or higher degree, 16 years of statistical programming experience, Technical skills, Communication skills, Leadership skills, Lead and manage large team, Develop successful offshore team, Work across different time-zones, Advanced SAS analysis and reporting, Advanced R analysis and reporting, Prior regulatory submission experience, Thorough understanding data quality, Experience working globally dispersed team, Prior staff development leadership, Project management experience, Excellent oral English skills, Excellent written English skills, Perform complex statistical programming

Nice to Have

MSc or higher degree, Familiarity with open-source tools, Familiarity with automation platforms, Familiarity with emerging technologies

What You'll Do.

Ensure successful execution analysis deliverables

Ensure successful execution regulatory submission packages

Implement programming strategies

Plan project progress

Monitor project progress

Address project issues

Provide GSP product input

Develop resource plans

Manage resource plans

Monitor assigned staff

Utilize assigned staff

Drive piloting new technologies

Integrate new technologies

Improve functional maturity

Lead departmental initiatives

Participate in departmental initiatives

Lead cross-functional groups

Participate in cross-functional groups

Represent GSP in audits

Represent GSP in inspections

Develop controlled documents

Review controlled documents

Implement controlled documents

Provide hands-on support

Provide coaching staff

Provide mentoring staff

Provide input career development

How You'll Work.

Team & Collaboration

Global Statistical Programming; Cross functional consultancy; Submission Consultancy Group; ADaM Consultancy Group; Cross-functional working groups

Communication Scope

Written communication; Oral communication

Process & Methodology

Project management

Full Job Description

## **Career Category** Clinical ## ## **Job Description** **Associate Director, Biostatistical Programming** **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. **Associate Director, Biostatistical Programming** **What you will do** Let’s do this. Let’s 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 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-sou

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