Principal SAS Programmer at HAYS

Posted in Other 11 days ago.

Location: New York, New York

Job Description:

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Clinical Research Organization is seeking a Principal SAS Programmer in New York, NY.

Role Description

The Principal SAS Programmer independently leads the programming activities for various purposes including CSRs, DSMBs, interim analyses, manuscripts, etc. Mainly supports statistical programming of statistical analysis plan (SAP)-planned tables, data listings, and graphs for CSRs, as well as integrated summaries of safety and efficacy, ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, programs, programming table of contents, and patient profiles.

In addition, the Principal SAS Programmer supports migration activities in the creation of Standard Data Tabulation Model (SDTM) and production of the Analysis Data Model (ADaM). The Principal SAS Programmer is also responsible for monitoring and meeting assigned program milestones, and will coordinate and lead a team of programmers to accomplish tasks.

• Participation on projects dealing with the assessment, design and/or implementation of data standards (e.g., CDISC SDTM and CDASH).
• Perform Gap Analysis on studies requiring migration to CDISC standards to ensure all documentation and datasets necessary to perform the migration activities are present and without issue. Work with the migration team and client to resolve any issues.
• Annotate case report forms (CRFs) according to the CDISC Implementation Guideline for migration to SDTM.
• Create SDTM specifications document based on CDISC Implementation Guideline.
• Follow standardized SDTM migration programming procedures to create quality Standard Data Tabulation Model (SDTM) compliant SAS datasets and Define.XML documents
• Create analysis datasets (e.g., ADaM) specifications based on Statistical Analysis Plan (SAP) or any study analysis algorithm.
• Design or write program specifications based on consultations with Biostatistical programming and Biostatistical staff.
• Lead Programming Project teams by assigning tasks, reviewing their programs, and working with business partners and the client to establish timelines for all deliverables.
• Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.
• Analyze SAS code to find causes of errors and revise programs.
• Write and maintain documentation of changes to SAS code, programs, and specifications.
• Revise programs for corrections, enhancements, or system environment changes.
• Coordinate with other programmers about program revisions.
• Modify and maintain SAS programs written by others.
• QC SAS programs for Dataset, Tables, Listings, and Figures following the departmental QC procedures.
• Train and mentor new hires and junior SAS Programmers, following established standardized design and programming procedures.
• Create Define XML; Define PDFs, and Reviewers Guides.
• Apply CDISC knowledge (SDTM and ADaM) standards to dataset programming.
• Consult with Sponsors on technical and/or regulatory issues.
• Provide technical training to other staff members.
• Coordinate quality improvement initiatives.
• Assist in establishing standardized programming procedures and work instructions; develop, enhance, evaluate, and validate standardized macros and utility programs; ensure that regulatory requirements are met through validation/compliance activities; develop and maintain clinical processing work flow systems.
• Assist in the development of client proposal documents; and represent the company at client technical meetings.
• Create statistical analysis outputs to be used in support of final reports, abstracts, posters, manuscripts, and other clinical publications; support systems to produce electronic regulatory submissions.
• Lead individual projects as well as large drug development programs, including integrated summaries of safety and efficacy.

Skills & Requirements

• Bachelor's Degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 10 years of SAS programming experience with clinical trial data OR Master's Degree in in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 8 years of SAS programming experience with clinical trial data.
• Good working knowledge of CDISC SDTM and ADaM Implementation Guidelines.
• Excellent knowledge of regulatory requirements and drug development process.
• Excellent organizational skills and verbal/written communication skills.
• Ability to work independently as well as lead programming teams.
• Strong communication skill set with peers, business partners, and Sponsors.
• Strong Analytical mindset.
• Leadership skills to lead project team to deliver high quality deliverables on time and working directly with the Sponsor to meet the project delivery expectations.
• Must be fluent in English (written and verbal).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information.

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