Clinical Data Manager - Katalyst Healthcares & Life Sciences
Boston, MA 02108
About the Job
Requirements:
- Perform sample size calculations and write statistical methodology sections for inclusion in study protocols.
- Oversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents.
- Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissions.
- Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicable.
- Develop SAS programs to produce and/or QC statistical tables/figures/data listings.
- Perform mapping from raw datasets to CDISC SDTM datasets.
- Produce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submission.
- Develop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor and CDISC SDTM datasets from raw data.
- Review and/or write the statistical and results sections of clinical study reports
Requirements:
- Minimum of 3 years of experience in statistical analysis of clinical trials data or Minimum of 2 years of experience in statistical analysis of clinical trials data if relevant PhD degree has been obtained.
- Master's degree in Biostatistics, Mathematics, Statistics, Public Health or related discipline required; PhD degree in Biostatistics, Mathematics, Statistics, Public Health or related discipline preferred.
- Previous experience working for a CRO required.
- Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods.
- Knowledge of other statistical and data management software packages is a plus.
- Strong written and oral communication skills.
- Knowledge and experience with CDISC data standards and models.
- Strong project management and mentoring/leadership skills.
Source : Katalyst Healthcares & Life Sciences