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Clinical SAS Programmer - Remote

Fairfield, CT

Posted: 06/10/2024 Industry: Biotech/Pharmaceutical Job Number: 5706

Job Description

Contact: Linda Aronova – laronova@penfieldsearch.com

No 3rd party applicants

Responsibilities:

  • Independently develop/validate programs that generate SDTM and analysis datasets based on ADaM specifications.
  • Prepare/QC ADaM datasets documentation: Define.xml, Reviewer’s Guide and analysis metadata report.
  • Independently develop/validate programs that generate tables and listings specified in the protocol or the Statistical Analysis Plan (SAP)
  • Perform quality control on final reports.
  • Provide QC and validation reports.
  • Support development of technical programming specifications for ADaM standards
  • Communicate with programming and statistics leads, data managers and other team members.
  • Provide project progress updates of programming activities.

Requirements:

  • BS/MS in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences
  • 10+ years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry
  • Strong SAS programming skills required in Windows & UNIX environment with proficiency in SAS/Base, SAS Macros, SAS/Stat
  • Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide and SAS Studio is a plus.
  • Experience with all clinical phases I, II, III and IV of trials is desirable.
  • Good understanding of standards specific to clinical trials such as CDISC, SDTM, ADaM, MedDRA, WHODRUG
  • Strong problem-solving skills
  • Good organizational and time management skills
  • Excellent communication skills and capability of communicating technical concepts.
  • Excellent organizational skills with demonstrated success to multi-task and deliver viable solutions in a fast-paced environment with changing priorities.

Meet Your Recruiter

Corey Marshall
Director, Strategic Partnerships

Corey Marshall comes to Penfield leveraging a decade of industry knowledge as a trusted advisor to pharmaceutical, biotech, and medical device companies. His track record and network support his capabilities in helping sponsors to streamline development, strengthen operations, and bring products to market efficiently. Corey has worked across the product development lifecycle, from early development through commercial readiness, helping bridge various technical and regulatory challenges in complex programs with tailored solutions.

As the Director of Strategic Partnerships, Corey manages our Clinical group where he leads scalable, flexible resourcing models that deliver capable expert support across Clinical Operations, Medical Affairs, and various trial execution functions. Penfield has built this model to integrate seamlessly with sponsor teams and alleviate risk within the Sponsor/CRO engagement.

In addition to his technical background, Corey has supported several early-stage start-ups in gaining critical investment funding from angels, family offices and venture capital groups.

 

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About Fairfield, CT

Ready to take your career to new heights? Explore job opportunities in beautiful Fairfield, Connecticut, where coastal charm meets bustling city life. This vibrant area offers a perfect blend of picturesque beaches, historic landmarks like the Fairfield Museum, delectable local cuisine, and a thriving arts scene including the Regina A. Quick Center for the Arts. With proximity to New York City and easy access to outdoor recreational activities at places like Lake Mohegan, Fairfield is an ideal location for professional growth and work-life balance. Don't miss out on the chance to join this dynamic community – browse our job listings today!