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Principal Statistical Programmer FSP

Cytel
USA
Full-time
Lead · 8+ years experience
Onsite
Discovered 3 weeks ago

Full Job Posting

Qualifications

  • Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
  • MS in biostatistics or a related field, with 8+ years of experience in pharmaceutical industry, or BS in biostatistics or a related field, with 10+ years of experience in pharmaceutical industry,
  • Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
  • Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
  • Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
  • Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
  • Must be able to work independently
  • Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
  • Outstanding communication skills (written and verbal) and strong leadership skills
  • Excellent and transparent communication skills and ability to influence across multiple functions
  • Experience with BLAs, MAAs and other regulatory submissions is a plus

Responsibilities

  • As a Principal Statistical Programmer, your responsibilities will include:
  • Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor
  • Provides technical and project management leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
  • Provides leadership to ensure compliance with company SOP'S and FDA/ICH/GCP regulations
  • Conducts briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects with significant consequences and impact
  • Performs quality control checks of advanced SAS code for datasets and output produced by other Statistical Programmers
  • Performs review on define.xml and create reviewers guide for SDTM and/or ADaM datasets
  • Review, maintain study documents per standard process
  • Program, test, and document global utility programs and tools in accordance with standards and validation procedures
  • Perform other duties as assigned

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