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Sr. Principal Statistics

Upcoresolutions

Paramus, NJ

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JOB DETAILS
SKILLS
Analysis Skills, Biotech and Pharmaceutical, Case Report Form (CRF), Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Clinical Practices/Protocols, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Data Quality, Data Sets, Data Structures, Database Design, FDA (Food and Drug Administration), ICH Regulations, Identify Issues, Industry Standards, Interpersonal Skills, Leadership, Licensing, Marketing, Multitasking, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Regulations, Regulatory Submissions, SAP, Statistical Programming Languages, Statistics, Surveillance, Time Management
LOCATION
Paramus, NJ
POSTED
2 days ago

Our client is looking for a Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing.

RESPONSIBILITIES:

  • 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
  • Other duties as assigned

QUALIFICATIONS:

  • 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

PHYSICAL AND MENTAL REQUIREMENTS:

  • Ability to multitask
  • Adapts to change
  • Maintain composure under pressure
  • Ability to follow verbal or written instructions and use of effective verbal communications
  • Adapts change, adjust change and grasps information quickly
  • Examine and observe details

About the Company

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Upcoresolutions

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