Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Validate and create SDTM, ADaM, and Tables, Figures, and Listings (TFLs), including associated documentation like define.xml using SAS.
- Write or review data specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).
- Hands-on statistical programming to support CSR, publications, presentations, DSUR, IB update, safety data review, reconciliation, ad hoc analyses, patient profiles, and monthly safety reports in a fast-paced environment.
- Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.
- Assist in the development of template programs or macros and standard specifications to improve efficiency in the Statistical Programming group.
- Work on multiple tasks at same time and prioritizes tasks to meet timelines on a regular basis.
- Collaborates with Biostatisticians, Clinical Data Management, and Clinical Research Scientists on studies when needed.
- Support RWE data curation and summaries in coordination with Biostatistics.
- May assist with testing R and relevant R packages to either validate or develop R-based code solutions.
Requirements:
- Bachelor's or higher degree in Statistics, Math or Computer Science or other suitable qualification related to the field.
- 8+ years of statistical programming experience in the pharmaceutical industry Strong SAS programming and statistical background along with experience with Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS.
- Basic level of R knowledge or experience using R and relevant R packages (tidyverse, admiral, etc.) is preferred.
- Thorough understanding of clinical trial design as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
- Experience working with oncology trials, PK analysis, and NDA or BLA submissions.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Strong hands-on programming skills to deliver results in a fast-moving environment with the ability to work independently when only given loosely defined specifications.