Vertex Pharmaceuticals-posted 5 days ago
$161,803 - $204,200/Yr
Full-time • Principal
Remote • Boston, MA
5,001-10,000 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 to meet specifications
  • act as a subject matter expert for all the end users
  • perform all the report development, data analytics and configuration in Elluminate application
  • Generate and maintain all required documentation
  • supporting clinical programming and data management staff in their effective use of SAS for data review
  • 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
  • Employer will accept a Bachelor's degree or foreign equivalent in engineering, computer science or a related field and 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
  • medical
  • dental
  • vision benefits
  • 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)
  • annual bonus
  • annual equity awards
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