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Expert Clinical Programmer

Novartis -
Hyderabad, Telangana

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Job details

Full-time

Qualifications

SAS
R
Data management
Communication skills
Python

Full job description

Summary

Responsible for configuring and managing the Central Monitoring Platform by translating study requirements into data-driven solutions, while developing and maintaining Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Data Quality Analytics/Statistical Monitoring tests to enable proactive risk detection. The role also involves building central monitoring dashboards and reports with accurate data ingestion, harmonization, and visualization for effective study oversight, and acting as a technical, cross-functional collaborator by working closely with Central Monitors, study teams, and stakeholders to ensure data quality and overall trial success.

About the Role

Key Responsibilities

Implement solutions for RBQM, data review and cleaning, as defined in data quality plans and enable the detection of data quality insights.
Manage configuration of system to support data ingestion, transformation and provisioning required standard and study specific outputs ( e.g. KRIs, QTLs ). Use SAS or Python programming skills while developing required outputs.
Troubleshoot and resolve routine technical issues related to build, transformations, reports, and visualizations.
Support post‑production changes by performing impact analysis and helping implement approved change requests.
Participate in key study milestones such as database go‑lives, dry runs, interim snapshots, and database locks.
Support system upgrades and validations, including impact assessments and execution of validation activities.
Develop and maintain study documentation, ensuring accuracy, completeness, and compliance with standards.
Collaborate with internal teams and vendors, act as subject matter expertise while continuously sharing knowledge within the team.

Essential Requirement

Minimum 6 years of experience in clinical review and report programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry
Strong knowledge of any programming languages (SAS, Python, R etc.)
Knowledge of Data Review and/or Business Intelligence tools (such as Central monitoring platform)
Understanding of clinical data management systems and/or relational databases as applied to clinical trials
Ability to translate technical concepts for non- technical users in the areas of central monitoring platform design and visualization development
Strong verbal and written communication skills to work with our global partners and customers
Understanding of Drug Development Process, ICH- GCP, CDISC standards and Health Authority guidelines and regulations

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)

Division

Development

Business Unit

Development

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Alternative Location 1

Mumbai (Office), India

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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