Director Stat. Programming - Sdsqm (hybrid)

539

$190,800.00 - $300,300.00; bonus/equity: eligible ...
Hybrid
Sdtm data deliverables
Cdisc data standards experts
Regulatory guidance and submission standards
This job posting is for a Director of Statistical Programming within the Biostatistics and Research Decision Sciences (BARDS) department at a major pharmaceutical company. The role involves leading a team to ensure compliance with regulatory standards for clinical data submissions, while also promoting collaboration across various departments

Job Summary

  • The Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical breakthroughs.
  • The Director is accountable for a team of CDISC data standards experts, sets the strategic and operating direction for the SDSQM SC team, and effectively collaborates with stakeholders at all levels in Biostatistics, Clinical Research, Data Management, Regulatory Affairs, and IT.
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits.

Matching Summary

Match Score: 85

This job posting is for a Director of Statistical Programming within the Biostatistics and Research Decision Sciences (BARDS) department at a major pharmaceutical company. The role involves leading a team to ensure compliance with regulatory standards for clinical data submissions, while also promoting collaboration across various departments.

Salary

$190,800.00 - $300,300.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, retirement, paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • SDTM data deliverables
  • CDISC data standards experts
  • regulatory guidance and submission standards
  • clinical trial programming
  • regulatory agency requirements

Nice-to-have

  • strategic thinking
  • process improvement
  • work across cultures and geographies
  • active in professional societies

Key Requirements

  • BS plus 12 years or MS with 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