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Senior Statistical Programmer

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Mid-level (2-5 years)

Work from:

Offer summary

10-15+ years of statistical programming experience in pharma/biotech, Experience with SDTM, ADaM specifications, TFLs, regulatory submissions.

Support statistical programming activities for clinical studies and maintain standards
Manage CROs, review deliverables, and execute statistical programming tasks for multiple studies

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

Responsibilities:

Support statistical programming activities for clinical studies, ensure statistical programming deliverables are delivered within timelines.
Maintain statistical programming standards, processes, and SOPs.
Manage CRO and review deliverables for accuracy and compliance, performing acceptance check and validation.
Manage, review, and/or execute statistical programming deliverables for planned statistical analysis related to study monitoring, clinical study reports, data integrations, and regulatory query responses, covering multiple studies.
Generate TFLs to support ad hoc requests.
Review data management documents (CRF specification, data transfer agreements, DMP, annotated CRF), SDTM and ADaM specification, SAP, and TFL shells to provide statistical programming feedback.

Requirements:

10-15+ years of statistical programming experience in the pharma/biotech industries.
Must be able to independently develop SDTM and ADaM specifications (DDT) and program, develop and validate TFLs.
Recently creating define.xml using Pinnacle 21 Enterprise.
Must have recent experience supporting regulatory submissions.
Define package experience and ISS/Client experience.
Strong experience with regulatory submissions activities (BLA/NDA).