- Assess and clarify requirements, contribute to developing programming specifications, providing programming solutions and ensure their efficient implementations.
- Provide support to the Biostatistics team in the review of the statistical analysis plan, writing of derived dataset specifications and the formatting of report documents and tabulations.
- Implement the statistical analysis plan by the creation of SAS programs to produce tables, listings, and figures.
- Clinical data support and non-analysis plan programming for team members outside of Biostatistics.
- Validate, maintain, and document programs.
- Identify system and process improvements, and to develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting.
- 5+ years in statistical programming within the Biotechnology and/or Pharmaceutical industry.
- Strong understanding of statistical programming requirements for regulatory submissions.
- Excellent SAS Software Programming skills, including experience with SAS/STAT, advanced DATA step, SQL and macro development to solve complex programming tasks.
- Knowledge of SDTM and ADaM programming requirements and practices. Ability to define and implement new SDTM and ADaM domains.
- Experience with statistical analysis of oncology studies
- Understanding of biostatistics, data management and the clinical trial process.
- Knowledge of statistical regulatory guidance and standards (e.g., FDA, ICH and EMEA)
- Strong knowledge of the CDISC SDTM and ADaM model
Additional Knowledge & Skills
- Experience with relational databases.
- Excellent written and verbal communication skills are required.
- Excellent analytical, problem solving and organization skills
- Ability to work independently and in ?a team environment.
- Excellent problem solving skills.
Minimum of a Bachelor’s Degree in a computing, life science, mathematical or statistical subject.