Senior Principal SDTM Programmer (d/f/m)

Oct 01, 2021

Job Description

8 biosimilars are already approved! Even more are in development (analytical and clinical research). You contribute to future submissions through close collaboration with our Statistical Programming Team and other departments.

Your responsibilities:
The Senior Principal SDTM (Study Data Tabulation Model) Programmer is responsible for overseeing all SDTM programming aspects of various studies (including both images and conversions) at the project level (including submissions and post-marketing activities). This is a role as a key contributor and strategic partner with additional responsibility to ensure that Sandoz Biopharmaceuticals drug development plans are executed effectively, on-time, and high quality results by ESP (External Service Provider).
Your responsibilities include, but not limited to:
• Oversight (and support governance) of the ESP or Novartis (for in-house SDTM programming deliverables) data provisioning activities to ensure the on time and qualitative creation and validation of outputs for CSR (Clinical Study Reports), submissions, approvals and Health Authority interactions
• Liase with Standards group to ensure Sandoz BCD (Biopharma Clinical Development) standards are in line with updated requirements
• SDTM decision making and strategy recommendation for Sandoz BCD studies
• Provide SDTM programming advice, expertise and input into SDTM process development
• Establish and maintain an effective working relationship with cross-functional teams and ESP partners when working on individual studies in accordance with the agreed contract and internal business guidelines. Ability to summarize the status of results and critical programming aspects/requirements (schedule, scope) and to discuss these with the internal and/or ESP study team
• Review of eCRF (electronic Case Report Form) and other ESP deliverables e.g. SDTM and raw data, ensuring the incorporation of industry standards (e.g. CDISC – Clinical Data Interchange Standards Consortium) and standardization at the partnership level that enables pooling and effective submission package production.
• Provision and implementation of SDTM solutions; ensuring the exchange of knowledge; function as SDTM programming expert for problem solving aspects
• Keeping advanced knowledge of programming software (e.g. SAS – Statistical Analysis Software), industry requirements (e.g. CDISC aCRFs, SDTM, RGs (Reviewers Guide), eCTD (electronic Common Technical Document), Define.xml) up to date, participation in functional meetings, work streams and training including any relevant trainings provided by the wider Novartis group
• Function as subject matter expert (SME), or as assigned to process improvements (non-clinical project initiatives where there is a focus on SDTM programming/transformation

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
BioPharma SZ
Holzkirchen (near Munich)
Research & Development
Full Time
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Senior Principal SDTM Programmer (d/f/m)

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