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Search for Jobs by Ali Henderson

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Remote Lead SAS programmer (Science & Biotech)
Bay Area, CA 94080
Recruited by: Ali Henderson | Recruiter | SimulStat Inc. See all my Jobs

  • Hiring Company: Simulstat's client
  • Industry: Science & Biotech
  • Compensation: Depends On Experience
  • Expires: Feb 14, 2023
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Job Description

Target profile is 12-15 years experience; although this position is focused on hands-on programming, experience as a lead is preferred

Prefers if candidates are located in Pacific Time Zone because they need afternoon coverage. If candidates can commit to core 9am-4pm PST hours M-F, they can be located in other time zones. Please confirm with candidates.

Remote, 12-month contract with potential to renew

Senior Statistical Programming Consultant

Responsibilities:
Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/ISE to FDA, EMA, and other worldwide regulatory agencies
Participate in the review of statistical analysis plans and TLF specifications
Review or annotate CRFs for SDTM mapping, review/author SDTM/ADaM dataset specifications
Review, and comment on CRFs, vendor data transfer specifications (DTS), edit checks and other study data related documents
Support in the preparation of study reports, regulatory submissions, and annual safety update reports
Perform additional analysis and validation for data checking, publication, presentation, poster and ad hoc analysis
Work with CRO statistical programmers and perform statistical programming vendor oversight
Contribute to Biometrics SOPs and work instructions related to EDC studies, FDA requests, and statistical programming processes
Contribute to department process improvement initiatives
Support department infrastructure build up by developing, validating and testing the macros, utilities and tools
Keep abreast of literature and advancements in SAS.
Qualifications:
Bachelor’s or Master’s degree in biostatistics, computer science, or related fields, Master’s degree preferred;
At least 12 years of relevant experience, including as a Lead Statistical Programmer, in the biotech or pharmaceutical industry.
The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
Proficient of SAS programming in a regulated clinical research environment
Experience of programming and validation of SDTM and ADaM data sets, tables, figures, and listings.