Senior Principal Statistical Programmer

    • Hyderabad, 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.

• Lead statistical programming activities as Trial Programmer for several studies or as a Lead/ Program Programmer for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization.
• Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study or project level.
• May act as functional manager for local associates including providing supervision and advice to these programmers on functional expertise and processes.
• Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as SP representative in study- or project-level team.
• Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient CRT production.
• Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. CSPD and other project-level strategies).
• Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects.
• Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project.
• 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 advanced 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.
• Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance
• Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.

Minimum requirements
• BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field. Ideally 7+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry
• Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs
• Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications
• Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs
• Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures)
• Proven communications and negotiation skills, ability to work well with others globally and influence
• Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others

Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.

Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

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