Flare Therapeutics

SAS Programming Director, Contractor – Part-Time

Flare Therapeutics

contract

Posted on:

Location Type: Remote

Location: Massachusetts • United States

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Job Level

Lead

Tech Stack

Google Cloud PlatformSQL

About the role

  • 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

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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SAS/BaseSAS/MacroSAS/STATSAS/GraphSAS/SQLCDISC SDTMCDISC ADaMtechnical programming specificationsrelational databasesintegrated summary safety/efficacy analyses
Soft Skills
communicationcollaborationorganizationalself-motivatedresults-orientedability to manage multiple prioritiesability to meet tight timelines