Biostatistical Programming Senior Associate (POPPK/PD)

Amgen Technology; Hyderabad; On-site; INR 1,200,000 - 2,100,000; Full time

Benefits offered by this job

Global exposure

Career growth

Health benefits

Job summary

Amgen India in Hyderabad seeks a Biostatistical Programming Senior Associate to perform hands-on statistical programming for complex data analyses in clinical studies and regulatory submissions. The role involves SDTM/ADaM dataset creation and validation, tables, listings, and figures, and collaboration across global teams.

The position requires 4+ years of programming experience in clinical development, strong SAS skills, and familiarity with PK/PD data.

Qualifications

• BA/BSc or higher in biostatistics, statistics, mathematics, computer science, or related fields with at least 4 years of statistical programming in a clinical development setting.
• Familiarity with CDISC SDTM/ADaM standards and ability to implement them in datasets and reports.
• Proficiency in SAS with experience in creating complex tables, listings, and figures for clinical trials.
• Excellent English communication, and ability to collaborate across global, cross-functional teams.

Responsibilities

• Analyze and report clinical trial data using SAS and/or R.
• Create and validate SDTM, ADaM datasets for safety and efficacy.
• Create and validate complex tables, listings, and figures for reports and regulatory submissions.
• Prepare statistical programming specifications and related regulatory documents.
• Maintain tracking and validation documentation.
• Collaborate with cross-functional teams to ensure data quality and consistency.
• Interact with study team members globally and support Study Lead Programmer as needed.
• Lead small PK/PKPD datasets projects (PopPK/PD) where assigned.

Skills

SAS/STAT

CDISC SDTM

CDISC ADaM

Define standards

R programming

Python programming

English communication

Team leadership

Education

BA/BSc or higher in biostatistics or related

MSc or higher in statistics/biostatistics

Tools

SAS

NONMEM

R

Python

Job description

Biostatistical Programming Senior Associate (POPPK/PD)

Join us.

Biostatistical Programming Senior Associate

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 a Biostatistical Programming Senior Associate, you will perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions.

Key Responsibilities:

• Analysis and reporting of clinical trial data using SAS and/or R
• Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy
• Creation and validation of complex tables, listings, and figures, both safety and efficacy
• Prepare statistical programming specifications
• Prepare statistical programming related documents for regulatory submissions
• Maintain tracking and validation documentation
• Collaborate with cross-functional team and create and/or validate complex programs for checking data quality
• Interact and collaborate with study team members from other functions globally
• Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP

For those assigned to the creation of Population PK and Population PK/PD datasets, key responsibilities may also include but not limited to:

• Create input datasets (ADPPK/PopPK, ADPKPD/PopPKPD, and ERPK) for NONMEM software to support Population PK and Population PK/PD analyses conducted by the Clinical Pharmacology Modelling and Simulation (CPMS) team.
• Create and review of PKPD and ERPK specification mappings.
• Serve as the backup Lead and support for at least one PopPK/PD project at a time.
• Manage individual programming assignments to ensure timely delivery of high-quality datasets and outputs.

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 4 years of statistical programming experience in relevant career statistical programming experience in a clinical development environment.
• Familiarity with drug development life cycle and excellent skills with the manipulation, analysis and reporting of complex clinical trial data
• Ability to effectively perform complex statistical programming and related tasks
• Ability to provide quality output and deliverables in adherence with challenging timelines
• Ability to work effectively on multiple tasks or projects across therapeutic areas
• Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
• Working knowledge of latest CDISC SDTM standards and familiar with CDISC ADaM and Define standards with strong ability to implement the standards
• In depth knowledge of SAS/STAT packages
• Familiar with data quality and compliance check tools
• Excellent oral and written English communication skills

If assignment includes the creation of Population PK and Population PK/PD datasets:

• Ability to lead small team projects effectively, willingness and ability to provide guidance to team members on technical and process questions
• Experience working with phase 1, 2, and 3 studies
• Familiarity with pharmacokinetic and pharmacodynamics data

Preferred Skills

• MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
• Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming
• Prior regulatory submission experience for drug approval

If assignment includes the creation of Population PK and Population PK/PD datasets:

• Experience developing specifications for other programmers
• Experience in understanding PK data workflow.

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