Senior Statistical Programmer
- Hyderabad, India
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 responsibilities include, but are not limited to:
• Lead statistical programming activities as Trial Programmer for phase I to IV clinical studies or assigned project-level activities. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work. Make statistical programming recommendations at study level. Contribute to project level standards
• Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), e.g. as member of the Clinical Trial Team (CTT).
• Review eCRF, discuss data structures and participate in data review activities.
• Comply with company, department and industry standards (e.g. CDISC) and processes, review and develop programming specifications as part of the analysis plans.
• Provide input into statistical programming solutions and/or ensure their efficient implementation. In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project 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.
• Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance
• Contributes to assigned parts of process improvement, standardization and other non-clinical initiatives
• BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field with Ideally 5+years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry.
• Good SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables. Good experience in contributing to statistical analysis plans and/or constructing technical programming specifications
• Good 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).
• Good communications and negotiation skills, ability to work well with others globally
• Proven ability to produce timely and quality deliverables under guidance
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: https://talentnetwork.novartis.com/network
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