Who We Are

Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of "Bringing Clinical Trials to Life," we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, Rare and Orphan Diseases, and pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.

Job Summary

The SAS Programmer is responsible for executing programming activities in coordination with project teams with supervision. S/he will develop, create, verify/validate and maintain managing the programs for assigned projects in compliance with standard operating procedures.

Essential Duties & Responsibilities

• Participates in the validation of SAS programs and maintains validation documentation.
• Familiarizes oneself with the SAS dataset structure and format catalogue related to a given study.
• Familiarizes oneself with the documents associated with a given study. Such documents include (but are not limited to) edit check documents, SAS and database annotated Case Report Forms (CRFs), visit map/schedule of events, CRFs, code lists, statistical analysis plan (SAP), data management plan (DMP), clinical protocol, programming-specific documentation.
• Develops, programs and maintains:
  • SAS edit checks and SAS edit check listings.
  • Subject profile programming used for quality control of paper-based project databases.
  • Data line listings as requested by the Sponsor and/or internal project teams.
  • Clean subject programming is used to identify clean subjects for a given project.
  • Review objects and registry of SAS datasets.
  • SAS programs are used to generate random samples of subject numbers and calculate database reliability rates during the quality control of paper-based project databases.
  • Programs that download external data received from various data sources.
  • External data reconciliation programs.
  • Programs that generate CRF and Query metrics.
  • Ad-hoc Sponsor and internal programming requests.
• Develops, programs and maintains site payment report programming; understands and utilizes the project Clinical Trial Agreement (CTA) to determine payment algorithm and amounts. Involves working closely with the project manager, Sponsor and Clinical Research Associates (CRAs).
• May present software demonstrations, training sessions, project-specific instructions at Sponsor meetings or visits or other presentations.
• May provide technical guidance and direction to lower-level personnel.

Degree & Experience

Knowledge & Skills

DEGREE & EXPERIENCE

• Bachelor's degree in the relevant field of study or B.S. equivalent.
• Minimum 5 years experience in clinical research required.

SPECIFIC KNOWLEDGE

• Possess an intermediate level of understanding of data management practices and clinical data management systems (CDMS).
• Possess an intermediate level of understanding of the Clinical Data Interchange Standards Consortium (CDISC) domain and item names and the role of CDISC in drug development.
• Understands the sequence of running programs to ensure up-to-date data and troubleshoot, debug programming problems and identify data trends.

SKILLS

• Intermediate proficiency in BASE SAS, SPSS or other statistical software is desired, but not required.
• Intermediate proficiency in database software is desired.
• Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as required.

• Effective verbal and writing skills; English + local language, if relevant