Manager, Statistical Programming

ManagerManagerFull TimeRemoteTeam 10,001+Company SiteLinkedIn

Location

United States

Posted

16 days ago

Salary

$133.2K - $172.4K / year

Bachelor Degree7 yrs expEnglishGoogle Cloud Platform

Job Description

• Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting. • Serves as project leader • Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries. • Successfully interacts within Biometrics, with Clinical Development and Regulatory Affairs groups on a frequent basis • Actively share experience and discuss possible process enhancements at programming meetings • Recommends potential trainings • Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures • Responsible for all programming activities within a therapeutic project or equivalent • Implements strategic initiatives • Able to lead and manage multiple concurrent projects

Job Requirements

  • BS degree in Biostatistics/Computer Science or equivalent and 7 years’ experience in pharma/biotech -OR - MS degree in Biostatistics/Computer Science or equivalent and 4 years’ experience in pharma/biotech –OR - PhD degree in Biostatistics/Computer Science or equivalent
  • 2 years of experience in pharma/biotech
  • Degree in Biostatistics/Computer Science or equivalent
  • 6+ years of pharmaceutical/CRO experience
  • Prior experience in oncology, hematology, and cell therapy is strongly preferred
  • Knowledge of long term follow up trial knowledge strongly preferred
  • Hands-on experience in pivotal studies and/or regulatory submissions (NDA, BLA, MAA, etc.)
  • In-depth understanding of clinical programming and/or statistical programming processes and standards
  • In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH)
  • Extensive experience with statistical programming using the SAS software including development and use of SAS Macros
  • Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)
  • Proven experience in leading programming activities
  • Excellent interpersonal, communication, problem solving, and analytical skills.

Benefits

  • Discretionary annual bonus
  • Discretionary stock-based long-term incentives
  • Paid time off
  • Company-sponsored medical, dental, vision, and life insurance plans

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