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Principal SAS Programmer

San Diego, CA

Order: 53240

Company Overview:

 

Creating value by bringing together the right people to achieve results is our motto. Our clients and employees say they choose to work with us because of how we work with them - with service that exceeds their expectations and a personal commitment to their success.

 

Our client, a biopharmaceutical company focusing on development of novel synthetic bile acid analogs to treat chronic liver diseases, seeks an accomplished Principal SAS Programmer.

 

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*** Candidate must be authorized to work in USA without requiring sponsorship ***

 

Description:

  • Responsible for supporting statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs.

  • This person will also provide technical expertise to the development of SAS programming standards and procedures.

  • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications.

  • Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files. Perform quality control for SAS programs and other study documents (e.g., presentations and reports).

  • Maintain complete and auditable documentation of all programming activities. Review output across SAS programs to ensure consistency.

  • Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.

  • Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.

  • Participate in the development and/or maintenance of departmental procedures and standards. Review CRFs, edit check specifications, and table mock-ups.

  • Works effectively with cross functional groups, study team, and vendors. Participates in monitoring CRO activities and reviewing CRO deliverables as necessary.

  • May assist in creation of table, figure, or listing mockups under supervision of statisticians. May train and mentor new programmers.

 

Qualifications:

  • Bachelor’s degree in Statistics, Mathematics, or Computer Science or in a related field.

  • Minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.

  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.

  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.

  • NDA submission experience is a plus.

 

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I'd love to talk to you if you think this position is right up your alley.

 

If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you. We're driven, people driven.


Satwinder Singh

Lead Technical Recruiter


Tel: 925-297-6495


Email:
satwinder.singh@evergentgroup.com

 

 

NOTE: Candidates that are offered a position are required to pass pre-employment drug and background screening. Qualified candidates with criminal histories, are considered in a manner that is consistent with local, state and federal laws.