Band
Level 4

Job Description Summary
LI-Hybrid
Location: Hyderabad, India

Bring your expertise in advanced statistics to the forefront of pharmaceutical manufacturing. In this role, you will play a key part in applying advanced statistical methodologies and process analytical technologies to improve process understanding, strengthen product quality and compliance, and enhance manufacturing performance. You will partner with manufacturing sites, quality, technical, and regulatory teams across the global network to transform complex data into actionable insights, applying statistical science to support risk-based decision-making, process optimization, root cause investigations, lifecycle management, and continuous improvement.

Job Description
Key Responsibilities:

Statistics
- Operate as a statistical subject matter expert, leveraging statistical principles and data-driven methodologies to support scientific decision-making, risk assessment, investigation conclusions, and process improvements.




- Represent the statistical function in cross-functional and regulatory interactions, including discussions with Health Authorities, to communicate, defend, and justify statistical approaches, analyses, and conclusions.
- Provide advanced statistical support for deviation investigations by applying techniques such as Regression Analysis, ANOVA, Multivariate Data Analysis (MVDA), Principal Component Analysis (PCA), and Partial Least Squares (PLS) to identify critical factors, evaluate process variability, and accelerate root cause investigations.
- Apply statistical process control and process capability methodologies to support Ongoing Process Verification (OPV), monitor process performance, identify trends, and evaluate manufacturing consistency. Guide cross-functional teams in the correct interpretation and application of statistical concepts.
- Provide statistical expertise for dissolution similarity assessments, including method selection, data analysis, reporting, and r

📌 Statistics & Process Analytical Technology Expert (Hyderabad)
🏢 Novartis
📍 Hyderabad