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Statistical Programmer Job Opening In San Francisco California – Now Hiring Katalyst Healthcares & Life Sciences


Job description

Responsibilities:

  • Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/Client 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 builds up by developing, validating, and testing the macros, utilities, and tools.


  • Keep abreast of literature and advancements in SAS.




Requirements:




  • Bachelor's or master's degree in biostatistics, computer science, or related fields, master's degree preferred.


  • At least 8+ 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.



Required Skill Profession

Other General


  • Job Details

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3362 Jobs in United States
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72 Jobs in San Francisco, California
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