Statistical Programmer

329548BR
Oct 11, 2021
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 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 minimal guidance participates in establishing successful working relationship on individual studies with external associates according to agreed contract and internal business guidance.



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

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Global Drug Development
GDO GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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329548BR

Statistical Programmer

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