Katalyst CRO
Overview
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Statistical Programmer
role at
Katalyst CRO . 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. Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time. Proficient in SAS programming in a regulated clinical research environment. Experience programming and validating SDTM and ADaM data sets, tables, figures, and listings.
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Join to apply for the
Statistical Programmer
role at
Katalyst CRO . 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. Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time. Proficient in SAS programming in a regulated clinical research environment. Experience programming and validating SDTM and ADaM data sets, tables, figures, and listings.
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