Associate Director, Programming

DirectorDirectorFull TimeRemoteTeam 1,001-5,000Since 1999H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

35 days ago

Salary

$164.1K - $246.1K / year

Bachelor Degree10 yrs expEnglishSDLC

Job Description

• Own one or more enterprise capabilities within Programming Standards and Technology from concept to global rollout—defining roadmap, architecture, and implementation strategy, including change management • Lead the development and lifecycle management of ADaM standards, implementation guidance, and enabling technology components • Accountable for driving execution of project-based initiatives and operational goals, ensuring solutions are aligned with internal business needs, external requirements, and industry best practices • Collaborate with the Programming Leadership Team (LT) and standards governance forums to identify priorities, pilot opportunities, and monitor adoption of capabilities • Provide technical direction and mentorship to supporting subject matter experts (SMEs), resolving complex programming or implementation challenges • Represent Statistical Programming in cross-functional governance and decision-making forums to maintain visibility and alignment with partner functions (i.e. Biostatistics, Data Management, IT, QA) • Continuously improve processes, standards, and technology by staying abreast of evolving global regulatory requirements and industry trends • Oversee regulatory compliance (e.g., 21 CFR Part 11) through effective governance, ensuring systems and documentation remain audit-ready for GxP operations • Provide support for cross-pillar projects and operational needs across the Standards and Technology portfolio including compliance and operational reporting, system validation, audit/inspection support for clinical programs and technology platforms

Job Requirements

  • 10+ years of relevant experience in the Pharmaceutical/Biotech Industry
  • Bachelor’s or Master’s degree in statistics, biostatistics, computer science, or a related field
  • Skilled SAS programmer with strong knowledge of CDISC ADaM models, efficient coding practices, and contextual understanding of clinical data
  • Knowledge and experience leading the development of dynamic, reusable code
  • Understanding of metadata-driven automation frameworks and their application to scalable ADaM creation
  • Practical experience applying SDLC to the development, maintenance, and validation of standard code
  • Analytical, thorough, and proactive, with the ability to manage multiple tasks independently while maintaining high quality and accountability
  • Active participation in industry organizations (e.g., CDISC, PHUSE), including contributing to working groups or standards discussions, a plus.

Benefits

  • 401(k) Plan: 100% match on the first 6% of contributions
  • Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
  • Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
  • Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
  • Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
  • Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

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