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Job Summary
Title: Senior Statistical Programmer
Company: CRO/ FSP
Location: Remote
Type: Permanent Role
Notes: No Corp to Corp
Job Description:
Creates statistical programs using SAS to generate or Validate TLFs and derived datasets for regulatory submissions.
Performs and documents programming validation of TLFs, and derived data sets created by other programmers and/or statisticians.
Performs ad-hoc programming requests as required to support the Clinical Development department
Reviews and provides feedback on case report form designs, CRF annotations, DB structures, edit checks, and SAPs
Creates and maintains SAS Macros to create standard formatted output and assist with automation of routine tasks.
Creates, validate and documents mapping specifications for derived datasets.
Assist with CDISC implementation, particularly SDTM / ADaM datasets, define.xml, and specifications.
Provides direction/oversight of statistical programming work being conducted by CROs, and contractors.
Generation of ad hoc analyses, as necessary.
Assist in the review, synthesis and interpretation of analysis results.
Responsibilities:
Education: B.Sc. / M.Sc. in Statistics, Mathematics, Computer Science, Engineering or a related field. M.S. preferred.
At least 6 plus years of experience with SAS in pharmaceutical, biotechnology industry or CRO is required.
Previous experience in converting and/or creating datasets in CDISC (Clinical Data Interchange
Standards Consortium) format strongly preferred.
Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro language
Good knowledge of clinical trial design concepts.
Excellent communication and interpersonal skills.
Knowledge of relevant regulatory guidelines and standards (e.g., FDA, ICH and EMA).
Solid interpersonal and teamwork skills.
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