Director Stat. Programming - Sdsqm (hybrid)

29

Base: $190,800.00 - $300,300.00; bonus/equity: eli...
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Sdtm data deliverables
Cdisc data standards expert
Regulatory agency requirements
** The company seeks a Director of Statistical Programming within its Biostatistics and Research Decision Sciences department, responsible for leading a team that ensures compliance with regulatory data standards and delivers high-quality statistical analysis for clinical trials. The role requires extensive experience in statistical programming, project management, and a deep understanding of regulatory requirements in drug development, with a focus on collaboration and leadership. **

Job Summary

  • The Director provides leadership for the successful implementation of SDTM data deliverables required for analysis, reporting, and regulatory submission.
  • The role involves leading a team of submission consultants, staying current with regulatory guidance, and providing domain expertise to stakeholders.
  • The company offers a comprehensive package of benefits including medical, dental, vision healthcare, retirement benefits, paid holidays, vacation, and compassionate and sick days.

Matching Summary

Match Score: 75

** The company seeks a Director of Statistical Programming within its Biostatistics and Research Decision Sciences department, responsible for leading a team that ensures compliance with regulatory data standards and delivers high-quality statistical analysis for clinical trials. The role requires extensive experience in statistical programming, project management, and a deep understanding of regulatory requirements in drug development, with a focus on collaboration and leadership. **

Salary

Base: $190,800.00 - $300,300.00; Bonus/Equity: eligible for annual bonus and long-term incentive; Benefits: medical, dental, vision healthcare and other insurance benefits, retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days

Skills & Requirements

Must-have

  • SDTM data deliverables
  • CDISC data standards expert
  • Regulatory agency requirements
  • Clinical trial programming
  • Analysis and reporting deliverables

Nice-to-have

  • Process improvement
  • Work across cultures and geographies
  • Active in professional societies
  • Strategic thinking
  • Stakeholder engagement and influence

Key Requirements

  • BS plus 12 years or MS plus 10 years experience
  • 2 years statistical programming experience
  • 7+ years project management experience
  • US and/or worldwide drug or vaccine regulatory application submission experience
  • Leadership level experience

Work Rights

Not specified

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