Principal Statistical Programmer Analyst

Job Responsibilities:

• Act as a study lead and statistical programmer for the Biostatistics and Statistical Programming project team.
• Direct the programming activities of other programming personnel, and monitor progress on programming deliverables.
• Participate in sponsor meetings and kick-off meetings as a Statistical Programming representative.
• Develop specifications and mock-up display for outputs according to statistical and sponsor requirements.
• Develop technical programming specifications for SDTM/ADaM datasets and creation of analysis datasets conforming to Clinical Data Interchange Standards Consortium (CDISC) standards.
• Participate in programming and quality control of analysis datasets, tables, listings, figures and other programming activities.
• Prepare Define XML, Define PDFs, and Reviewers Guides for FDA submission process.
• Annotate electronic case report forms (eCRF) following CDISC published guidelines.
• Create specifications for data mapping of existing raw clinical data to CDISC compliant SDTM datasets.
• Ensure the compliance of SDTM and ADaM datasets to submission standards using CDISC Pinnacle 21 validator and provide solutions to identified issues.
• Perform various statistical analysis including the Kaplan-Meier survival analysis, Cox proportional hazards regression modeling, mixed effects modeling (including MMRM analysis), CMH test, Fisher test, ANOVA, ANCOVA and t-testing etc.
• Use SAS® software for the production of datasets, tables, listings, figures and other outputs requested per programming specifications, Statistical Analysis Plan and other study related documentation.
• Direct supervision of approximately ten (10) Statistical Programmer Analysts, including overseeing the performance and development of team members and conducting regular performance evaluations

General Requirements:

• Master of Science degree in Applied Mathematics, Statistics, Data Analytics, or a closely related field.

• At least TWO (2) years of experience in the job offered or at least TWO (2) years of experience in the following:

• Statistical analysis of clinical trials using SAS®
• Statistical analysis methods, including the Kaplan-Meier survival analysis, mixed effects modeling (including MMRM analysis), CMH test and ANOVA/ANCOVA
• Supporting Phase I, II and Phase III clinical trials in Autoimmune, Gastrointestinal, Neuroscience and Oncology Therapeutic Areas
• Creating dataset specifications according to CDISC and e-Sub standards
• Preparing and submitting reports as required by regulatory agencies, including Development Safety Update Reports, Investigator’s Brochure and Clinical Study Report
• Pinnacle21 software
• Directing the programming activities of other statistical programming personnel, including direct supervision of at least three Statistical Programmer Analysts
• If offered employment must have legal right to work in U.S.  EOE.