Associate Director, PKPD / Pharmacometrics / NONMEM / SAS Programmer

India

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
Good 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

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

Ready to make an impact? Apply now and be part of a team that is transforming the future of healthcare!

Similar jobs