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Statistical programmer

Remote:

Full Remote

Experience:

Expert & Leadership (>10 years)

Work from:

Offer summary

Minimum of 10 years experience in statistics, Strong SAS programming skills required.

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

51 - 200 Employees

Responsibilities:

Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget.
Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences.
Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications.
Lead statistical programming activities for regulatory submissions following CDISC standards.
Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan.
Take ownership for the completion of SDTM and ADAM specifications for assigned studies.
Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
Thorough knowledge of SDTM/ADaM specifications and programming
Strong SAS programming and graphic programming skills
Able to guide the successful completion of major programs and projects.
Strong analytical and communication skills

Requirements:

10 years of related experience with a bachelor's degree in Statistics; or 7 years and a master's degree; or a PhD with 4 years' experience.
Experience of leading both early and late-phase clinical studies including programming and validation of sets, tables, figures, and listings
Strong level SAS programmer with experience in delivering complex programming assignments, macros, and analyses.
Experience with oncology trials is preferred.
Experience with R is a plus.
Experience with SAS Graphics is a plus.
Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus.
Experience in management of CROs with respect to statistical programming.
Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization.