Associate Director, Pkpd / Pharmacometrics / Nonmem / Sas Programmer (Karnataka)

AstraZeneca; India; On-site; INR 6,000,000 - 9,500,000; Full time

Job summary

AstraZeneca in India seeks an Associate Director PKPD Pharmacometrics NONMEM SAS Programmer to lead programming for pharmacometrics analyses and data preparation across study and compound levels.

The role emphasizes SDTM/ADaM data handling, regulatory submissions, and cross-functional leadership with a focus on early and late-stage drug development within a data-driven pharmacology framework.

Qualifications

• 10 years of hands-on SAS programming experience
• Strong understanding of PK/PD in drug development
• Proficient in SAS & R programming
• Expert knowledge of SDTM/ADaM data prep and programming
• Regulatory submissions experience and interdisciplinary leadership
• Experience across early and late-stage drug development
• Fluent English communication skills
• Experience with multiple programming languages (SAS, R, Python)

Responsibilities

• Prepare programming for Pharmacometrics analyses and validate data
• Pool SDTM/ADaM data across studies for analysis-ready datasets
• Support Pharmacometrics Modeling and Simulation using NONMEM and related tools
• Contribute to regulatory documents and regulatory interactions
• Lead data integration and visualization tool development
• Ensure compliance with GCP and regulatory standards

Skills

SAS programming

R programming

Python

Pharmacokinetics

Pharmacodynamics

CDISC SDTM ADaM

Regulatory submissions

Leadership

English communication

Data integration

GCP compliance

Education

Bachelor's degree

MS preferred

Tools

NONMEM

SAS

R

Python

Monolix

MATLAB

Job description

Associate Director PKPD Pharmacometrics NONMEM SAS Programmer

Job Title Associate Director PKPD Pharmacometrics NONMEM SAS Programmer Global Career Level E

Introduction to role

Are you interested in shaping the future of drug development? We are looking for an Associate Director PKPD Pharmacometrics NONMEM SAS Programmer to join our Clinical Pharmacology and Quantitative Pharmacology Data Programming team. In this position you will be responsible for preparing programming, validating and diagnosing data to support Pharmacometrics and Clinical Pharmacology analyses. You will be instrumental in influencing critical decision making throughout all phases of drug development and regulatory interactions.

Accountabilities

As an Associate Director PKPD Pharmacometrics NONMEM SAS Programmer you will be responsible for expert data cleaning, manipulation, transformation and integration at both the study and compound level. You will apply advanced data integration techniques that directly contribute to the value of each study and compound. Key responsibilities include pooling data from study and compound-level SDTM ADaM datasets to prepare analysis-ready data for Pharmacometrics Modeling and Simulation M S software such as NONMEM. This work will play a critical role in informing study design, dose selection, dose justification, and guiding go no-go decisions. Additionally you will contribute to regulatory documents and internal initiatives that advance the Pharmacometrics discipline and ensure compliance with Good Clinical Practice GCP regulations.

Essential Skills

• Experience: 10 years of hands-on experience in SAS programming in preparing pooled data sets across studies
• Strong understanding of pharmacokinetics, pharmacodynamics and their application in drug development
• Strong SAS & R programming skills
• Expert knowledge of data preparation and programming practices CDISC SDTM ADaM
• Demonstrated data programming and clinical development expertise
• Positive knowledge of global regulatory compliance processes standards
• Capability to develop tools to support data integration visualization
• Bachelor s degree MS preferred with relevant experience required
• Demonstrated experience in regulatory submissions and interdisciplinary team leadership
• Varied programming languages SAS R Python
• Experience in early and late-stage drug development
• Excellent problem‑solving, communication and project management skills
• Proficient oral and written English communication skills
• Knowledge in pharmacology, drug targets and core therapy areas (e.g. oncology, respiratory, renal, metabolism, etc.)
• Quantitative Scientific background: Statistics, Engineering, Biological Science

Desirable Skills

• Experience: Demonstrated expertise in data preparation and programming to support Pharmacometrics Modeling and Simulation M S software e.g. NONMEM
• Monolix R Matlab
• Scientific publishing in the field on pharmacometrics

Culture and Values

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life‑changing medicines.

In‑person working gives us the platform we need to connect work at pace and challenge perceptions.

That’s why we work on average a minimum of three days per week from the office.

But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our unique and ambitious world.

At AstraZeneca we are committed to making a difference by fusing data and technology with scientific innovation to achieve breakthroughs in healthcare.

Our dynamic environment encourages creativity and bold decision‑making as we strive to treat, prevent, modify and even cure complex diseases.

With a focus on collaboration and inclusivity we unite diverse global knowledge to create impactful solutions for patients worldwide.

Curiosity thrives as we explore new ways to handle diseases and push the boundaries of science.