statistical programmer

Looking statistical programmer (Remote role)
Long term

Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure highquality within timeline and budget
Conduct handson validation/QC of CRO deliverables to ensure highquality (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 reviewers guide annotated CRFs) conforms to SOPs and to regulatory specifications
Conduct handson programming of deliverables including but not limited to IDMC meetings DSUR IB safety data review Board meetings Exploratory Analysis etc.
Ensure timely delivery of all statistical deliverables for each study assigned
Collaborate with study statistician and study team members to come up with timelines for statistical programming deliverables and other related action items
Follow departmental SOPs and processes for operational excellence
Lead statistical programming activities for regulatory submissions following CDISC standards
Review key studyrelated 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
Knowledge:

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
Knowledge and experience in meeting regulatory guidelines including both FDA and international regulatory agencies
Broad knowledge of medical/biological terminology in relevant therapeutic areas

Experience:

12 years of related experience with a Bachelors degree in Statistics; or 8 years and a Masters degree; or a PhD with 5 years experience
Experience of leading both early and latephase clinical studies including programming and validation of SDTM and ADaM data 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

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