Contract Sr. SAS Programmer- San Diego Job at SimulStat's Client, San Diego, CA

MWJoVFV3ZEZ0TWhPekZGY1B1MXUyVnVPYkE9PQ==
  • SimulStat's Client
  • San Diego, CA

Job Description

Onsite - San Diego 12 month renewable contract Responsibilities will include, but are not limited to, the following:

  • Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
  • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
  • Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
  • Perform programming validation to ensure the quality of analysis datasets and programming outputs.
  • Ensure consistency and adherence to standards within the project.
  • Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.
  • Create Data Definition Tables (DDT) and converting TFLs to the required format for eSubmission.
  • Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
  • Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
  • Serve as the lead programmer in support of NDAs, sNDAs.
  • Serve as an advisor to programmers assigned to the project to ensure high quality and timely deliverables.
  • Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.
  • Contribute to the creation, maintenance, and validation of standards for outputs and macros.
  • Provide training on SOPs, WPs and standard programs.
  • Contribute to the creation of naming conventions and development of the programming environment.
  • Oversee the services provided by CROs.
Skills/Knowledge Required:
  • Bachelor’s Degree in life science, statistics, mathematics, computer science, or related field is required; Master’s Degree is preferred.
  • 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions.
  • Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
  • Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
  • Demonstrated skills in using additional software tools and applications (e.g. MS office, XML).
  • Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
  • Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
  • In-depth understanding of regulatory, industry, and technology standards and requirements.
  • Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
  • Demonstrated ability to work in a team environment with clinical team members.
  • Good planning and project management skills.
  • Good interpersonal, communication, writing and organizational skills.

Job Tags

Contract work, For contractors, Flexible hours,

Similar Jobs

EATEAM

Need R shiny with SAS Exp-Onsite Role Job at EATEAM

 ...Hi Need R shiny with SAS Exp-Onsite Role Location : Lawrenceville, NJ Duration: 12+Months Need R Shiny developer with SAS and should have atleast good experience working in a Clinical environment. Look for 8 to 10 years of experience in... 

Stellent IT LLC

AI/ML Scripting Engineer SME Job at Stellent IT LLC

 ...below details: # Updated Resume # Current Location # Visa Status # LinkedIn Id Job Title: AI/ML Scripting Engineer SME Location: Remote Job Description : Provide ongoing staff supplementation subject matter expertise... 

Akkodis

Launch Manager - Material Job at Akkodis

 ...Akkodis is seeking a Launch Manager for a job with our automotive client in Kokomo, IN. We are looking for someone with 4+ years of experience in Product Launch experience with Material Flow and Material Logistics with an automotive background. Rate Range:... 

China Global Connections

Humanities Teacher Job at China Global Connections

We are looking for Humanities Teacher for an International School based in Beijing. This is a full-time position starting in August 2025. About the schoolOne of the international bilingual education pioneers in China. The school committed to providing students with a well... 

micro1

Frontend Developer (m/f) Job at micro1

About the jobJob Title: Frontend DeveloperJob Type: Full-time or Part-TimeLocation: RemoteAbout Us:Our mission at micro1 is to match the most talented people in the world with their dream jobs. If you are looking to be at the forefront of AI innovation and work...