Flare Therapeutics

Trailblazing the path to target transcription factors and discover precision medicines for cancer & other disease areas

SAS Programming Director, Contractor – Part-Time

DirectorDirectorContractRemoteTeam 11-50H1B SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

6 days ago

Salary

Not specified

Bachelor DegreeEnglishGoogle Cloud PlatformSQL

Job Description

• Development and validation of technical programming specifications and programs • Generation of SDTM and ADaM datasets • Production of SAP-specific tables, listings, and figures • Management and documentation of all statistical programming activities • Implementation of process and technology improvements to enhance efficiency and quality • Contribute to the development and maintenance of SOPs and guidelines for statistical programming and ensure adherence across projects • Coordinate end-to-end programming deliverables in collaboration with cross-functional team members and vendors • Collaborate closely with internal stakeholders (Biostatistics, Clinical, Medical, Regulatory) and external partners (Full-Service and Functional Service Providers) • Ensure outsourced programming activities are performed according to GCP, approved SOPs, and study protocols • Monitor vendor deliverables and quality, escalating issues when needed • Support study- and program-level audit and inspection readiness activities

Job Requirements

  • Extensive programming project experience in DIOTECH/pharmaceutical companies or CROs, with a strong background in oncology solid tumor clinical trials
  • Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a Windows environment, with demonstrated mastery of SAS/STAT procedures
  • Strong experience with CDISC SDTM and ADAM standards and familiarity with eCTD submission requirements
  • Demonstrated success in managing programming deliverables across multiple studies and vendors
  • Deep understanding of drug development and the biopharmaceutical industry
  • Proven ability to manage multiple, competing priorities in a dynamic environment
  • Excellent communication, collaboration, and organizational skills
  • Self-motivated and results-oriented, with the ability to meet tight timelines
  • Advanced experience with:
  • Constructing technical programming specifications
  • Relational databases
  • Good Clinical Practices (GCP)
  • Good Programming Practices (GPP)
  • 21 CFR Part 11 Standards
  • Integrated summary safety/efficacy analyses
  • Safety data and coding dictionaries (MedDRA)

Benefits

  • Contract Position
  • Part time: 20 hours/week
  • 1 yr Duration

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