Clinical SAS Programmer Lead Analyst
Location
Remote
Posted by 
Tejaswi Rudresh on 23 Mar 2022
Job Start Date 23 March 2022
Job Type Fulltime
Sub Type W2-Salary
Payrate : Competitive rate All Inclusive
TFL SDTM Clinical SAS Programming ADAM Statistical Analysis Plan (SAP) CDISC SDTM Mapping Cro Tables Figures Listings
Description
Working within the Clinical Operations Department and Programming/Biostats functional unit,the Sr. Programmer Analyst is responsible for building programs to create SAS datasets from
the clinical database, external data sources, and other sources while following the clinical
study's protocol or statistical plans. This position is also responsible a number of other activities
related to the creation of statistical outputs for a clinical trial.
RESPONSIBILITIES:
• Prepare SOPs pertaining statistical programming.
• Follow departmental SOPs and guidelines
• Assure Good Clinical Practices, investigator integrity, and compliance with all study
procedures.
• Ensured completeness, accuracy, and consistency of the data so that it meets the
standards of quality expected for reporting to regulatory bodies while following Good
Clinical Practices (GCP) and FDA’s validation rules for submission datasets and SDTM IG
3.2.• Represent the department in client meetings/presentation and maintain a positive
working relationship with sponsors, collaborating associate and vendor personnel
• Provide coordination and functional management/oversight of programming and
statistical contractors
• Serve as the statistical programming lead on internal project teams and coordinate
programming, verification, and documentation of statistical programs for use in creating
analysis datasets, tables, and listings.
• Actively adapt and adjust priorities to ensure timely and quality completion of assigned
tasks
• Assist internal project team in identifying project priorities and communicating such
activities and associated timelines to departmental management
• Work independently to carry out assignments with occasional support from senior
management
• Contribute to ongoing improvement of programming processes and methodology
• Works closely with data management to identify issues in data quality
• Review CRF annotations and data specifications
• Develop programming specifications based upon the study protocol and statistical
analysis plan (SAP)
• Apply CDISC standards for SDTM and ADaM specifications when applicable
Trial Runners - Job Descriptions – Sr. Programmer Analyst - Version 1.0 – 22May2018
• Create persistent SAS datasets and table, figure, and listing outputs (TFLs) according to
study specifications and Statistical Analysis Plan (SAP)
• Perform validation programming for all programming deliverables
• Develop SAS macros and utility programs for repeat use across projects
REQUIREMENTS:
• Base SAS certification or the equivalent SAS programming experience, ideally in clinical trials and/or within a CRO context.
• Ability to communicate well in written and spoken English
• A commitment to working within a team and producing high quality results while
working under timeline constraints.
EDUCATION REQUIREMENTS:
• Bachelor’s degree (or higher) in Statistics, Computer Science, or other closely related
field to programming
• SAS Certification
• 3-5 years programming experience
Location:
PO Box 159 Langhorne PA
19047
19047
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