Summary

Responsible for all statistical programming/data review reporting and analytics development aspects of assigned studies or project-level activities. Acts as a key contributor in ensuring that drug-development plans are driven efficiently with timely and high quality deliverables.

About the Role

The number of New Molecular Entities (NMEs) approvals of potential blockbusters, which Novartis obtained in 2019 alone. We advanced a breath of early programs in our pipeline that addresses significant unmet needs and are looking for passionate and enthusiastic Statistical Programmers with expertise in SDTMs, ADaMs & TFLs, and experience in Regulatory Submissions. As a part of the Statistical Programming unit, you will play a key role in supporting a growing pipeline across multiple therapeutic areas, with emphasis on regulatory submissions. An excellent opportunity to work end-to-end programming from CRF collections through Regulatory submission, you will have an exciting opportunity to learn new technologies (like R) and endorse Statistical Programming as a key contributor in driving the #GO-Digital vision of Novartis.

Your key responsibilities:
Your responsibilities include, but not limited to:

• Contribute to statistical programming activities as Statistical Programmer for phase I to IV clinical studies or project level activities.

• Build and maintain effective working relationship with cross-functional team. Contribute to assigned parts of process improvement, standardization and other non-clinical initiatives.

• Review the eCRF, data structures and data review activities. Comply with company, department and industry standards (e.g. CDISC) and processes, create / support the review of programming specifications as part of the analysis plans.

• Ensure timely and quality development and validation of datasets and outputs (datasets, tables, figures and listings) for study-documents according to specifications.

• Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.

• Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.

• Under minimal guidance participates in establishing successful working relationship on individual studies with external associates according to agreed contract and internal business guidance.

Commitment to Diversity & Inclusion: : Novartis is committed to building an outstanding, inclusive work environment and diverse teams\' representative of the patients and communities we serve.
Role Requirements:
What you\xe2\x80\x99ll bring to the role:

• BE/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field with Ideally 2+ years of work experience in a programming role preferably supporting clinical trials.
• Basic SAS experience within a Statistical Programming environment to develop and validate deliverables.
• Basic experience in contributing to statistical analysis plans and/or constructing technical programming specifications.
• Basic understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP).
• Good communications and negotiation skills, ability to work well with others globally.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people\xe2\x80\x99s 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

You\xe2\x80\x99ll 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\xe2\x80\x99 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


Division
Development
Business Unit
Innovative Medicines
Location
India
Site
Mumbai (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


Novartis is committed to building an outstanding, inclusive work environment and diverse teams\' representative of the patients and communities we serve.