Director Stat. Programming - Sdsqm (hybrid)

Muckelab

$190,800.00 - $300,300.00; bonus/equity: annual bo...
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Sdtm data deliverables
Cdisc data standards expert
Regulatory agency requirements
** The Muckelab is seeking a Director of Statistical Programming within its Biostatistics and Research Decision Sciences division, focusing on the implementation of Study Data Tabulation Model (SDTM) data deliverables for regulatory submissions. The role requires extensive experience in statistical programming, project management, and leadership skills to oversee a team and ensure compliance with regulatory standards. **

Job Summary

  • The Director provides leadership for the successful implementation of SDTM data deliverables required for analysis, reporting, and regulatory submission.
  • The role involves setting the strategic and operating direction for the SDSQM SC team and collaborating with stakeholders across various departments.
  • 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 Muckelab is seeking a Director of Statistical Programming within its Biostatistics and Research Decision Sciences division, focusing on the implementation of Study Data Tabulation Model (SDTM) data deliverables for regulatory submissions. The role requires extensive experience in statistical programming, project management, and leadership skills to oversee a team and ensure compliance with regulatory standards. **

Salary

$190,800.00 - $300,300.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Comprehensive package including medical, dental, vision, retirement, paid time off

Skills & Requirements

Must-have

  • SDTM data deliverables
  • CDISC data standards expert
  • regulatory agency requirements
  • clinical trial programming
  • global and TA standards

Nice-to-have

  • change management
  • strategic thinking
  • process improvement
  • work across cultures and geographies

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

Work Rights

Not specified

Tailored Resume

Cover Letter