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.
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:

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

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