About the Role

Major accountabilities:

• Responsible for managing project level activities within Product Lifecycle Services (PLS). Act as the programming functional lead on customers' project teams. Participate in project team meetings. Determine an efficient project programming strategy that utilizes customers' standards and procedures. Develop project-level programming specifications for analysis datasets and pooled datasets for a project.
• Lead the production of statistical outputs for clinical study reports, publications, and market promotions. Ensure the quality control of all programs, specifications and statistical outputs within a study project.
• Ensure that programming-related documents are consistent, and comply with Data Science's and customers' standards, by reviewing case report forms, statistical analysis plans, data structures specifications, and specifications for tables, listings and figures. Archival of project programs and associated documentation.
• Mentor programmers in the functional expertise required for project support. Support the development of, and the training of users in, new programming applications.
• As required, participate in process improvement initiatives or other non-clinical project activities.
• Develop advanced, general-purpose programming functions for deployment across multiple projects. Maintain advanced knowledge of programming languages (e.g., SAS and R).
• Manage the outsourcing of programming activities from Data Science to an approved vendor in accordance with Scientific Services vendor management procedures.

Role Requirements :

Key Essentials:

• Graduation/Post graduation or equivalent experience in mathematics, statistics, computer science, or health sciences/related field with at least 8 years' work experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry (5 years for MS Statistics / Computer Science graduates). Advanced knowledge of / experience with SAS, or R, and other relevant programming software.
• Proven experience in development of advanced programming functions with high programming efficiency; strong programming and problem-solving skills
• Proven experience in leading programmer support for multiple clinical trials and submission activities (or
equivalent). Proven knowledge of database design/structures and basic statistics. Working experience in pooling analysis datasets across multiple clinical studies (or equivalent)
• Good understanding of global clinical trial / project practices, procedures, methodologies. Good understanding of regulatory requirements relevant to statistical programming (e.g. Good Clinical Practice).
• Good knowledge of office tools.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity & Inclusion: :

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
https://www.novartis.com/careers/benefits-rewards

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Development

Business Unit
Innovative Medicines

Location
India

Site
Hyderabad (Office)

Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regular

Shift Work
No