Offer summary

Qualifications:

BS or MS in Computer Science or Biostatistics / Life Sciences, Minimum of 6 years industry experience in Statistical Programming with CRO oversight.

Key responsabilities:

Create/validate SDTM/ADaM/TLFs programs

Provide oversight for CRO deliverables

Generate SDTM mapping specs and reviewer's guides

Prepare regulatory submission packages and support responses

Manage programming deliverables for multiple studies/projects

Job description

RESPONSIBILITIES:

Creation of SAS programs to Develop or Validate SDTM/ADaM/TLFs.
Provide oversight for CRO SDTM/ADaM/TLFs deliverables for multiple studies and make sure efficiencies are gained at project level.
Generate and/or review of SDTM mapping specifications, annotated CRFs, ADaM specifications, Define.XML documents and reviewer's guides per CDISC and FDA specifications and guidelines using standard tools and templates.
Interact with Biostatistics and Regulatory to design and prepare regulatory submission-ready packages and support responses to health authority information requests.
Provide technical leadership, problem solving of moderate to high complexity and within project timelines while providing high quality deliverables.
Demonstrate expertise in the SAS language, procedures, and options commonly used in clinical trial reporting - including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
Create all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/Client.
Accountable for oversight of Statistical Programming deliverables on project level for inhouse and outsourced projects.
Manage all aspects of Statistical Programming deliverables for multiple studies/projects.
Support in development and review of global standards, templates, processes, SOPs and Work Instructions.
Partner with cross functional groups on timelines, vendor selection and CRO oversight.
Expertise in the SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
Experience in development and validation of CDISC SDTM and ADaM data models by transforming raw data into standard domains and development and validation of Tables/Listings/Figures.
Extensive experience of data integration.

REQUIREMENTS:

BS or MS in Computer Science or Biostatistics & Life Sciences.
Minimum of 6 years of industry experience in Statistical Programming to include oversight of CRO deliverables.
Must possess the ability to work in a team environment.
Excellent written, verbal, and interpersonal communication skills.
Creation of all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/Client.
Good knowledge of 21CFR11 and GCP.