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Statistical Specialist


Novartis Healthcare Pvt. Ltd.

4 – 8 yrs Hyderabad / Secunderabad

Job Description:

Provide statistical support and driving the application of advanced and state-of-the-art statistical principles, tools and methodologies to improve process understanding, quality and compliance of the products, efficiency and capability of the processes and profitability of the organisation.
demonstrating validity and equivalence. Contribute to risk assessments, e.g. FMEA or risk matrix. Planning and evaluation of Design of Experiments (DoEs) in the frame of the Novartis Quality by Design validation strategy.
Trending analysis in the frame of Continuos Process Verification Implementation and application of Statistical Process Control principles, e.g. control charts, and other pattern recognition techniques.. Support the compilation of Annual Product Review (APR)/Product Quality Reviews (PQRs). Facilitate and enable (multivariate) process monitoring and control principles, e.g. by Multivariate Data Analysis (MVDA). Review of stability data and definition of Internal Release Limits (IRL).Interacts with internal and external Reg bodies and Health Authorities, as well as internal functions (development organization, RegCMC, QA/QC, Engineering, global MS&T) as appropriate (e.g. during inspections, investigations etc.) in statistical aspects of data analisis and rationales.

Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Analytics & Business Intelligence
Role Category:Analytics & BI
Role:Data Analyst


QA Statistical Process Control Design Validation Quality Compliance Data Analysis Statistical Specialist SAS R Minitab SIMCA – P+ Modde JMP SPSS

Desired Candidate Profile:


UG: B.Sc – Maths, Statistics
PG:M.Sc – Any Specialization

company Profile:

Novartis Healthcare Pvt. Ltd.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.

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