Statistical Programmer (Data & Statistical Sciences (DSS))

Role Summary

Statistical Programmer (Data & Statistical Sciences (DSS))

Responsibilities

• Interface with DSS.
• Serve as an integral project team member in R & D of new pharmaceutical products.
• Analyze & report clinical trial data under direction of Senior Statistical Analyst.
• Provide SAS programming support for clinical trials.
• Develop SAS programs for creation of Analyst Data Models (ADaM), data sets following CDISC standards for either production/validation with creating specifications for structure of ADaM data sets for individual studies.
• Develop SAS programs for creation of Tables, Listings & Figures for either production/validation, also responsible for accuracy of SAS programs by reviewing output, code, & log files.

Qualifications

• Education & Experience: Must possess a BS in Statistics, Biostatistics, Computer Science or related field, & 2 years of relevant statistical programming experience. Of experience required, must have 2 years of work experience in each of the following:
  • providing SAS programming support for pharmaceutical industry clinical trials;
  • coding SAS programs using SAS base;
  • utilizing SAS tools SAS/MACROS, SAS/SQL, SAS/GRAPH, & SAS/STAT;
  • developing ADaM specifications per CDISC standards;
  • developing ADaM datasets in compliance with CDISC standards & developing Tables, Listings, & figures;
  • creating documentation for regulatory filings including reviewers‚Äô guides & data definition documents, &
  • complying with FDA & EMEA regulatory agencies/ICH guidelines & relevant regulatory requirements.
• Alternatively, would accept MS in Statistics, Biostatistics, Computer Science, or related field & 6 months of relevant statistical programming experience. Of experience required, must have 6 months of experience in each of the following: (i), (ii), (iii), (iv), (v), (vi) & (vii).
• Experience may be gained concurrently. Any suitable combination of education, training or experience is acceptable.

Skills

• Hybrid (onsite 3 days a week/ 2 days WFH/remote)

Education

• BS in Statistics, Biostatistics, Computer Science or related field; or MS in Statistics, Biostatistics, Computer Science, or related field.