Ccrps
Job Description
Employer : Vertex Pharmaceuticals Incorporated
Job Title : Principal Clinical Programmer
Location : 50 Northern Ave., Boston, MA, 02110
Openings : 1
Responsibilities
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 Telecommuting permitted.
Requirements 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.
Rate of Pay : $161,803.00 – $204,200.00
Contact Send resume to futuretalent@vrtx.com. Reference 12140.763. EOE.
Disclosure Statement The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
Flex Designation Remote-Eligible
Flex Eligibility Status
Remote : work remotely five days per week and come into the office on occasion - you're always welcome on-site;
or select
Hybrid : work remotely up to two days per week;
or select
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.
Equal Employment Opportunity Statement 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
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Job Title : Principal Clinical Programmer
Location : 50 Northern Ave., Boston, MA, 02110
Openings : 1
Responsibilities
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 Telecommuting permitted.
Requirements 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.
Rate of Pay : $161,803.00 – $204,200.00
Contact Send resume to futuretalent@vrtx.com. Reference 12140.763. EOE.
Disclosure Statement The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
Flex Designation Remote-Eligible
Flex Eligibility Status
Remote : work remotely five days per week and come into the office on occasion - you're always welcome on-site;
or select
Hybrid : work remotely up to two days per week;
or select
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.
Equal Employment Opportunity Statement 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
#J-18808-Ljbffr