Katalyst CRO
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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 build 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. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
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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 build 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. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Statistical Programmer jobs in
Oakland, CA . Data Analytics & Engineering - Data Scientist
Senior Data Scientist, Algorithms - Primetime Pricing
Research Associate - AI (Eastern Standard Time)
Data Scientist, Algorithms - Primetime Pricing
San Francisco, CA $179,000 - $255,000 3 weeks ago Senior Data Scientist, Product, Googler Technology and Engineering
San Francisco, CA $156,000 - $229,000 1 day ago San Mateo County, CA $60 - $70 2 weeks ago San Mateo County, CA $200,000 - $250,000 3 weeks ago Alameda, CA $112,000 - $224,000 6 days ago Data Analyst - Accounting Operations, Process, and Systems
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