INC Research has flagged the Senior Statistical Programmer, Hyderabad / Pune job as unavailable. Let’s keep looking.

Job ID

394850BR

About the role

Position Title: Senior Statistical Programmer

About the role: Senior Statistical Programmer

Location – Hyderabad #LI Hybrid

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.

Key Responsibilities:

  • Lead and coordinate activities of all statistical programmers as Trial Programmer for phase I to IV clinical studies or assigned project-level activities. Make statistical programming recommendations at study level.
  • Build and maintain effective working relationship with cross-functional teams, 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 in accordance with the company, department and industry standards (e.g. CDISC). Processes, review and develop programming specifications as part of the analysis plans.
  • Provide input into statistical programming solutions and/or ensure their efficient implementation. Responsible for development of programming specifications of analysis datasets and pooled datasets.
  • Ensuring 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 guidelines. Contributes to assigned parts of process improvement, standardization and other non-clinical initiatives.

Position Title

Senior Statistical Programmer

Role Requirements

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 knowledge of industry standards including CDISC data structures as well as 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, standardization and other non-clinical initiatives.

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

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.

Job Type

Full Time

Country

India

Work Location

Hyderabad, AP

Functional Area

Research & Development

Division

Development

Business Unit

GCO GDD

Employment Type

Regular

Company/Legal Entity

Nov Hltcr Shared Services Ind

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.

Shift Work

No

Early Talent

No

Read Full Description
Confirmed 16 hours ago. Posted 7 days ago.

Discover Similar Jobs

Suggested Articles