Fulltime Position
Works closely with other programmers, biostatisticians, and clinical data managers with a leading role in the collection, analysis, and reporting of clinical data for phase I-IV clinical development programs.
Primary Responsibilities:
- Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets.
- Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specifications for analysis datasets.
- Following specifications, develops algorithms and writes programs to create datasets.
- Produces data listings, summary tables and graphs using SAS software.
- Independently checks data listings, summary tables and graphs.
- Imports and exports SAS data.
- Assists data management group in performing data edit checks.
- Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.
- Plays an active role in taking project solutions and generalizing them for the Biostatistics group.
- Interacts with the project statistician and guides other programmers participating on a project team.
Education/Experience/Skills:
Bachelor's degree in a statistics, computer science, or a similar quantitative field; an equivalent combination of relevant education and applicable job experience may be considered. Experience in programming with the Statistical Analysis System (SAS) beyond classroom work is required. Minimum of 5 years' experience in clinical statistical programming within pharmaceutical or related industry (biotechnology, medical device, Clinical Research Organization (CRO)). SAS Certified Base and/or Advance Programmer experience is preferred.
Must possess:
- Proven experience in SAS programming including base SAS, SAS/Stat, SAS/Graph, macros, ODS.
- Experience with SDTM and ADaM industry data standards.
- Exposure to statistical graphics software.
- Good communication skills and attention to detail are crucial.
- Proven ability to handle multiple tasks.
- Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
- Skilled at promoting team cooperation and a commitment to team success.
- Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.
Additional Information
Vipul Gupta
California Creative Solutions, Inc.
13475 Danielson Street Suite 220 / Poway, CA 92064
