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Open nowFirst seen 4 days ago

Sr. Principal Statistics

Globalchannelmanagement685 open roles

Where
Paramus, New Jersey, United States
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Your applicationOpen nowSr. Principal StatisticsGlobalchannelmanagement · Paramus, New Jersey, United States

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: first seen 4 days ago

The posting

Sr. Principal Statistics needs 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience

Sr. Principal Statistics requires:

  • SAS, ICH guidelines, CDISC data structures, FDA guidelines, SAP preparation, TFL shells, CRF review, database design review, edit check specifications, sample size calculation, analysis dataset validation, CRO oversight
  • Education: Ph.D. or MS in Statistics or Biostatistics
  • Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience
  • Excellent knowledge of SAS computer package
  • Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines
  • Excellent organizational skills, time management, and ability to meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others
  • Exceptional interpersonal skills and problem-solving capabilities
  • Ability to work independently and collaboratively
  • Ability to provide leadership for the CRO statisticians and statistical programmers

Sr. Principal Statistics duties:

  • Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
  • Review CRF, database design, and edit check specs
  • Review study quality surveillance plan and monitor study conduct
  • Prepare and/or review SAP, TFL shells and specifications for variable derivation
  • Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables
  • Provide statistical and validation support for statistical analysis, analysis datasets and TFL Review study report, manuscripts and other documents related to statistics
  • Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents
  • Perform other ad-hoc statistical activities as needed
  • Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming
  • Participates in monitoring CRO activities and reviewing CRO deliverables
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