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.

Vipul Gupta

California Creative Solutions, Inc.

13475 Danielson Street Suite 220 | Poway, CA 92064

Phone: 858-435-0206 | Fax: 858-683-2424