Sr. Statistical Programmer

– 6 month renewable contract
– Onsite San Diego

Sr. Statistical Programmer will lead all programming-related activities on multiple concurrent projects and oversee development of clinical study related deliverables and timelines for programming activities.

Responsibilities

  • Oversee CRO activities and review CRO deliverables
  • Monitor, analyze and report clinical trials data and generate outputs (Tables, Figures and Listings) according to study SAPs or ad-hoc request specifications in support of annual safety reports, study CSRs, regulatory submissions, business development activities and clinical publications
  • Participate in establishing the programming scope, timeline and quality for deliverables with stakeholders 
  • Perform quality control checks/validation of advanced SAS code and output produced by CROs for SDTM datasets, AdaM datasets, TFLs
  • Review project documentations such as specifications, issue logs, deliverable status, and the Statistical Project Plan (SPP) for accuracy and completeness
  • Assist in the validation of derived datasets, programming specifications and tables, listings and graphs
  • Create and maintain documentation for analysis dataset specifications and validation
  • Review and make recommendations for process development and improvement
  • Provide technical leadership and guidance for programming team and CRO
  • Collaborate with cross-functional teams including Data Management, Clinical Operations, and Medical Monitoring and CROs to review eCRF design and specifications, edit checks, data validation specifications, perform document user acceptance testing (UAT) on databases, and conduct clinical data quality reviews by providing SAS checks to verify integrity and consistency for completeness, accuracy, and suitability

 

Qualifications:

  • Master degree in statistics, computer science or a related field with at least 5 years (or Bachelor degree in statistics, computer science or a related field with at least 7 years) of SAS programming experience in the pharmaceutical or biotech industry
  • 2 years + oncology experience preferred
  • Proven ability to manage CRO relationships and oversees programmed deliverables
  • Advanced skills in SAS programming and statistical reporting
  • In-depth knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements
  • Advanced knowledge with FDA and ICH regulations and guidelines, medical terminology and clinical trial methodologies
  • Good communication skills