Senior Statistical Programmer
Senior Statistical Programmer
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Salary Not Disclosed
1 Vacancy
Job Description
- Validate and create SDTM ADaM and Tables Figures and Listings (TFLs) including associated documentation like using SAS.
- Write or review data specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).
- Handson 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 fastpaced 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 Rbased code solutions.
- Bachelors 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 handson programming skills to deliver results in a fastmoving environment with the ability to work independently when only given loosely defined specifications.
Employment Type
Full Time
