Statistical Programmer

6 months ago

Mumbai Maharashtra, India Novartis Full time

**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 executed 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 mínimal 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’ll 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.

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Division

Development

Business Unit

Pharmaceuticals

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.

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