Sr. Manager of Bio-Statistical Programming

  • location: Princeton, NJ
  • type: Permanent
  • salary: $140,000 - $150,000 per year
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job description

Sr. Manager of Bio-Statistical Programming

job summary:
**IMMEDIATE NEED for a lead Bio-Statistical Programmer to coordinate and manage all statistical programming activities to ensure statistical programming deliverables on schedule and according to quality standards from study start-up through archival for clinical studies.**

 
location: Princeton, New Jersey
job type: Permanent
salary: $140,000 - 150,000 per year
work hours: 9 to 5
education: Masters
 
responsibilities:
  • Act as the lead programmer for assigned projects to coordinate and manage all statistical programming activities to ensure statistical programming deliverables on schedule and according to quality standards from study start-up through archival for clinical studies
  • Establish and manage the partnership with Biostatistics vendors and participate in vendor selection for statistical programming services for clinical studies
  • Create, review, approve, and/or execute statistical programming plans for the statistical analysis and reporting of clinical study data, which include development of SDTM/ADaM data specifications, creation of SDTM/ADaM datasets and TFLs, performing QC of datasets and TLFs, conducting dry-runs and final analysis, and supporting ad-hoc analysis requests, etc.
  • Plan and oversee the programming activities for outsourced clinical studies and QC of datasets (SDTM/ADaM) and TLFs following CDISC/standards
 
qualifications:
  • A Master's degree or equivalent in Mathematics, Statistics, Biostatistics, Engineering, Computer Science, or related fields
  • 10+ years of working experience in pharmaceutical/clinical trial environment
  • Solid programing background and hands on experience on statistical programming in pharmaceutical/clinical trial environment
  • Good understanding of CDISC (SDTM/ADaM) data standards, statistical programming standards and related regulatory requirements
  • Broad knowledge and prior experience in NDA/BLA submissions in eCTD format and responding to regulatory agencies (e.g. FDA/EMA/PMDA) requests are preferable
  • Ability to work independently to identify and solve complex problems with minimal supervision
  • Experience working with vendors/CROs is preferred
 
skills: Biostatistical Analysis
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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