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Statistical Programmer Consultant

The Steely Group

Remote, CA(remote)

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JOB DETAILS
SKILLS
Biometrics, Biostatistics, Biotech and Pharmaceutical, Business Strategy, Case Report Form (CRF), Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Communication Skills, Computer Engineering, Computer Science, Consulting, Contract Research Organization (CRO), Data Analysis, Data Management, Data Sets, Database Report Tools, Establish Priorities, FDA (Food and Drug Administration), Medical Writing, Multitasking, Pharmacovigilance, Process Improvement, Project/Program Management, Regulations, Statistical Programming Languages, Statistics, Technical Writing, Time Management, XML (EXtensible Markup Language)
LOCATION
Remote, CA
POSTED
30+ days ago
Our client is looking to add a Statistical Programmer Consultant to their team on a contract basis.

Responsibilities:
  • Involved in the programming activities on multiple projects/ studies across various therapeutic areas, both internally and externally by CROs
  • Creates and reviews annotated CRF to SDTM datasets
  • Provides support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company' s strategic objectives
  • Functions as a positive role model for setting high expectations for quality, creativity and project ownership
  • Works collaboratively with Clinical Operations, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting
  • Provides technical input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers)
  • Works with Biometrics and other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate
  • Involved with the strategy for process improvement
  • Identifies new tools to increase efficiency and quality                                                                                                     
Requirements / Qualifications:
  • 8+ years of biotech or pharmaceutical industry experience as statistical programmer
  • BS or MS degree in Statistics, Biostatistics or Computer Science or Engineering. MS preferred
  • Strong experience in CDISC SDTM/ADaM programing
  • Strong SAS experience building complex Table, Listing and Figures
  • Direct experience with eCTD submissions(FDA/EMA/PMDA)
  • Experience with creating Define.xml, reviewer’s guide
  • Good communication skills, can work independently under supervision.

About the Company

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The Steely Group