Director Stat. Programming - Sdsqm (hybrid)

leHACK

$190,800.00 - $300,300.00; bonus + long-term incen...
Hybrid (3 days onsite, 1 day remote)
Sdtm data deliverables
Cdisc data standards expert
Regulatory agency requirements
The job posting is for a Director of Statistical Programming at leHACK, a role that involves leading a team to ensure compliance with regulatory standards for clinical trials and data submissions. The position requires extensive experience in statistical programming, project management, and collaboration across various departments in the pharmaceutical industry

Job Summary

  • The Director of Submission Consultation leads a team of CDISC data standards experts, setting strategic and operating direction for the SDSQM SC team.
  • This role requires deep understanding of both Late Stage and Early Stage Development business needs and regulatory requirements, including US and/or worldwide drug or vaccine regulatory application submission experience.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, and compassionate and sick days.

Matching Summary

Match Score: 85

The job posting is for a Director of Statistical Programming at leHACK, a role that involves leading a team to ensure compliance with regulatory standards for clinical trials and data submissions. The position requires extensive experience in statistical programming, project management, and collaboration across various departments in the pharmaceutical industry.

Salary

$190,800.00 - $300,300.00; Bonus and long-term incentive eligible; Comprehensive benefits package

Skills & Requirements

Must-have

  • SDTM data deliverables
  • CDISC data standards expert
  • regulatory agency requirements
  • clinical trial programming
  • analysis and reporting deliverables
  • submission consultation experience

Nice-to-have

  • strategic thinking and operational objectives
  • change management and influence
  • process improvement and stewardship
  • cross-cultural and global collaboration
  • active in professional societies

Key Requirements

  • BS plus 12 years or MS plus 10 years experience
  • 2 years statistical programming in clinical trials
  • 7 years project management experience
  • Leadership level regulatory submission experience
  • People management responsibilities

Work Rights

Not specified

Tailored Resume

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