Senior Statistical Programmer II

Vertex Inc.-posted 11 days ago

$124,600 - $186,900/Yr

Full-time • Mid Level

Remote • Boston, MA

1,001-5,000 employees

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Codes complex SAS programs (including Macro language, SAS/STAT and SAS/GRAPH) for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDlSC SDTM format; consistently meeting objectives of the study. Performs quality control checks of SAS code and output produced by other Statistical Programmers. Demonstrates proficient knowledge of clinical development and medical data. Solves clinical trial reporting problems and has a proven technical proficiency in supporting daily operations and ensuring that project tasks are completed accurately with limited supervision. Creates CDISC data sets by transforming various raw data sources, including different Electronic Data Capture (EDC) databases and Interactive Web Response Systems (IWRS), tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications. Works with all types of coding dictionaries (MedDRA and WHODD) commonly used by the pharmaceutical industry. Works in a team environment providing technical leadership and solving clinical trial reporting problems within budget and customary time line constraints while assuring high quality standards. Telecommuting permitted.

Codes complex SAS programs (including Macro language, SAS/STAT and SAS/GRAPH) for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDlSC SDTM format; consistently meeting objectives of the study.
Performs quality control checks of SAS code and output produced by other Statistical Programmers.
Demonstrates proficient knowledge of clinical development and medical data.
Solves clinical trial reporting problems and has a proven technical proficiency in supporting daily operations and ensuring that project tasks are completed accurately with limited supervision.
Creates CDISC data sets by transforming various raw data sources, including different Electronic Data Capture (EDC) databases and Interactive Web Response Systems (IWRS), tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications.
Works with all types of coding dictionaries (MedDRA and WHODD) commonly used by the pharmaceutical industry.
Works in a team environment providing technical leadership and solving clinical trial reporting problems within budget and customary time line constraints while assuring high quality standards.

Employer will accept a Bachelor's degree, or foreign equivalent, in Computer Science, Biostatistics, Statistics, Data Science, Engineering, Biology, Pharmacy or a related field and 5 years of experience in the job offered or in a Senior Statistical Programmer II-related occupation.
Alternatively, employer will accept a Master’s degree, or foreign equivalent, in Computer Science, Biostatistics, Statistics, Data Science, Engineering, Biology, Pharmacy or a related field and 2 years of experience in the job offered or in a Senior Statistical Programmer II-related occupation.
Position requires demonstrable experience in the following:
Writing SAS programs using SAS/BASE, SAS/MACRO, SAS/GRAPH, SAS/STAT, and SAS/SQL to map raw clinical data to CDISC compliant datasets and create tables, figures, and listings reporting results of clinical trials for investigational medications;
Knowledge on Metadata Submission Guidelines (MSG V2.0) and annotate CRF with SDTM variables;
Knowledge on generation of define.xml 2.1;
Perform quality control on vendor deliverables;
Review CRF design specifications, edit check specifications, manual data review specifications, and vendor data transfer specifications as study statistical programmer;
Knowledge on Clinical Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG) documents;
Reviewing Statistical Analysis Plan.

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.
At Vertex, our Total Rewards offerings also include 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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