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Clinical Programmer Principal

Semma Therapeutics

Semma Therapeutics

Software Engineering
Paddington, London W2, UK
Posted on Tuesday, July 2, 2024

Job Description

General Summary:

The Principal Clinical Programmer conducts and coordinates programming activities for multiple studies. As an advanced practitioner in data management programming, provides technical advice and support for programming activities to data management team. May oversee the work product of other programmers, ensuring high quality and timeliness.

Experience in Pharma/Biotech is essential.

Key Duties and Responsibilities:

  • Excellent understanding of SQL programming concepts and ability to write complex SQL programming code.
  • Ability to configure a study/project using an ETL tool and write complex SQL queries for report development.
  • Ability to ingest data from various data sources and also integrate the data from external applications using the ETL tool.
  • Very high understanding of the Phase I-IV clinical trial process
  • Experience working in the Clinical data management function.
  • Thorough understanding of the DM related study activities like CRF’s, reconciliation, Manual data reviews etc.
  • Ability to understand the department level SOP’s, WI’s
  • Knowledge about GxP systems and regulatory framework of the clinical systems
  • Required to handle the clinical studies in CDSM independently and with minimal supervision.
  • Collaborate with the stakeholders in CDSM (data managers, data review team, recon team) during the study and provide necessary Clinical programming input and provide solutions
  • Ability to keep track of the clinical study milestones and align them with timely delivery of the reports.
  • Ability to understand/speak in a concise and clear manner in all the department/study team level meetings and explain the issue/concerns from the programming point of view.
  • Ability to develop any programming guidelines/documents if necessary.
  • Providing creative programming solutions based on the day-to-day study and DM process challenges.
  • Ability to devise methodical approaches to solve the problems and proactively identify the possible risks/problems.

Knowledge and Skills:

  • High proficiency in Programming languages in CDMS like SAS/ETL and SQL Plus and good knowledge of data standards, such as CDISC and SDTM
  • High proficiency in Clinical Data Management procedures including good knowledge of Good Clinical Practices (GCP), 21 CFR part 11 and other regulatory requirements
  • Strong organizational, influencing, presentation, documentation, and interpersonal skills as well as a team-oriented approach.
  • Significant, demonstrated experience with clinical programming, clinical data management, CRO industry and data reporting along with languages such as SAS and SQL.
  • Proven ability to independently determine the most appropriate methods and procedures across Clinical Data Management projects
  • Displays strong writing and verbal presentation skills, ability to convey complex/technical information to a variety of audiences and build alignment around an issue

Education and Experience:

  • Bachelor's degree in a scientific or technical field (e.g. computer science)
  • Extensive years of relevant work experience in clinical or statistical programming in biotech or pharmaceuticals, or the equivalent combination of education and experience

Flex Designation:

Remote-Eligible

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com