Vertex Inc.-posted 12 days ago
$161,803 - $204,200/Yr
Full-time • Principal
Remote • Boston, MA
1,001-5,000 employees

Utilize SAS and other supporting tools to design, write, validate, and maintain programs to meet specifications in a quality, timely and productive manner following standard development procedures. Solid understanding of Clinical data warehouse platform (Elluminate), act as a subject matter expert for all the end users. Excellent programming skills to perform all the report development, data analytics and configuration in Elluminate application. Generate and maintain all required documentation, including the development of specifications, coding, and validation efforts in support of clinical studies. Acts as a technical resource, supporting clinical programming and data management staff in their effective use of SAS for data review. Ensure high-quality deliverables by providing senior review of study level, program level, and multi study core deliveries for accuracy. Attend sponsor audits and assist with in-progress audits. Provide application administration and technical support on core business packages including CRF, SAS, and supplemental packages such as migration mentor review, reporting tools, and custom functions. Serve on program teams to coordinate and lead development activities for clinical programming projects. Keep those responsible for project management informed of any issues that might impact project target dates, scope, or budget and proactively escalates potential problems, including resourcing. Assist in sponsor and internal audits, and regulatory inspections. Monitor the scope of work to actual work, alerting management of potential change orders. Manage and execute the change order to completion. Provide input and support details for change orders. Collaborate with clients, peers, lead programmers, project teams and requestors to clarify and finalize specifications, and use expanded technical skills to meet evolving project needs. Telecommuting permitted.

  • Design, write, validate, and maintain programs using SAS and other tools.
  • Serve as a subject matter expert for the Clinical data warehouse platform (Elluminate).
  • Develop reports, data analytics, and configurations in Elluminate.
  • Generate and maintain documentation for clinical studies.
  • Provide technical support to clinical programming and data management staff.
  • Review study, program, and multi-study deliveries for accuracy.
  • Attend sponsor audits and assist with in-progress audits.
  • Provide application administration and technical support on core business packages.
  • Coordinate and lead development activities for clinical programming projects.
  • Monitor project issues and escalate potential problems.
  • Assist in sponsor and internal audits, and regulatory inspections.
  • Manage and execute change orders.
  • Collaborate with clients and project teams to finalize specifications.
  • Bachelor's degree or foreign equivalent in engineering, computer science or a related field
  • 6 years of experience in the job offered or in a Principal Clinical Programmer-related occupation.
  • High proficiency in Programming languages in CDMS like SAS and SQL Plus and good knowledge of data standards, such as CDISC, STDM and CDASH.
  • Solid understanding of Elluminate and also possess excelling programming skills in to develop reports and also design data analytics in Elluminate.
  • High proficiency in Clinical Data Management procedures including good knowledge of Good Clinical Practices (GCP), 21 CFR part 11 and other regulatory requirements.
  • Significant, demonstrated experience with clinical programming, clinical data management, CRO industry and data reporting along with programming languages such as SAS.
  • Proven ability to independently determine the most appropriate methods and procedures across Clinical Data Management projects.
  • Interact with the end users of the CDMS (Clinical management systems) and convert their reporting requirements into programming specifications.
  • This role is eligible for an annual bonus and annual equity awards.
  • Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
  • inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
  • From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
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