333861BR
May 19, 2022
India

Job Description

5! 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 are not limited to:

• Lead statistical programming activities as Trial Programmer for either a large/pivotal study, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies.

• Co-ordinate and Mentor activities of all programmers either internally or externally assigned to the study/project work. Make statistical programming decisions/recommendations at study or project level.

• Build and maintain effective working relationship with cross-functional teams, discuss status of deliverables and critical programming aspects (timelines, scope, resource plan).

• Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT.

• Align with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level.

• Responsible for quality control and audit readiness of all assigned statistical programming results.

• Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance.


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Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:

Minimum Requirements :

• BA/BS/MS equivalent experience in mathematics, statistics, computer science, or health sciences/related field with Ideally 5+years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry.

• Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables.

• Good knowledge of industry standards including CDISC data structures. Advanced understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures).

• Good communications skills, ability to work well with others globally.

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!
Global Drug Development
GDO GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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333861BR

Principal Statistical Programmer

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