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.
An American Company is seeking a Remote Manager Statistical Programming
• Assist with the oversight of SAS programming personnel, including hiring, managing personnel matters, and conducting performance evaluations for relevant staff.
• Train SAS programmers regarding applicable regulatory guidelines and programming activities, including CDISC SDTM and ADaM standards to dataset programming, creating and validating SAS programs for Dataset, Tables, Listings, and Figures following the departmental QC procedures.
• Assist with resource allocation and with the development of business proposals related to Biostatistics and Programming.
• Serve as the programming lead on projects, as appropriate. As a project lead, the Manager, Statistical Programming develops and maintains a close liaison with client contacts, SAS programmers, biostatisticians, and project managers to drive the programmatic aspect of project delivery.
• Provide oversight of project-related statistical programming tasks, and performs project-related tasks, as required, including: communicating with Project Managers regarding resourcing to assure the appropriate staff is assigned to each study.
• Provide input into Case Report Form (CRF) and Data Validation Specifications (DVS) development in all therapeutic areas; writing specifications for analysis files, consistency checks, tables, and figures; analyzing clinical trial data producing accurate results representing the outcome of the trial; and validating statistical output.
• Provide input into statistical standard operating procedures (SOPs) and general standardization efforts within the department (e.g., statistical methodology standards, standard data presentations).
• Participate in interactions with regulatory agencies, as required.
Skills & Requirements
• Master’s degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 5 years of SAS programming experience with clinical trial data using CDISC SDTM and ADaM implementation guidelines OR Bachelor’s with a minimum of 8 years of SAS programming experience with clinical trial data using CDISC SDTM and ADaM implementation guidelines.
• 3 years of supervisory OR 5 years of project lead experience in a CRO required.
• Excellent working knowledge of CDISC SDTM and ADaM Implementation Guidelines.
• Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
• Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical and biotech companies.
• Excellent knowledge of regulatory requirements and drug development process.
• Excellent organizational skills and verbal/written communication skills.
• Strong communication skill set with peers, business partners, and Sponsors.
• Strong analytical mindset.
You will be working with a professional recruiter who has intimate knowledge of the 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.
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Hays is an Equal Opportunity Employer including disability/veteran.
In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570
Drug testing may be required; please contact a recruiter for more information. #1141892