A senior statistical programmer provides timely support to the study team on all programming matters according to the project strategies in Pharmacometrics Department in DSP. As an integral part of a study, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan, clinical pharmacolgy reports requirement and programming specifications using internal standards and guidelines. The incumbent assists in providing guidance in implementing and executing the programming and project standards. Supporting the evaluation and development of study requirements and validation plan are also in the scope of this position. Works independently to design and test program logic, coding programs, program documentation and preparation of programs. Meets statistical adhoc requests of senior management. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment.
•Responsible for transfer data from the LIMS (BA) and clinical data, prepare merged data sets for pharmacokinetic analysis.
•Create CDISC compliance analysis datasets (SDTM, ADaM) according to the SAP and programming specification
•Generate tables/figures to include but not limited to: accounting for the disposition of patients and samples, descriptive statistics of pharmacokinetic variables, and results, concentration over time, pharmacokinetic parameters over dose, concentration effect relationship, and PK/PD analyses.
•Support the electronic data submission for BLA
•Growth opportunity for this individual is in the area of Pharmacokinetics; both non-compartmental and compartmental, as in the use of NONMEM, pharmacokinetic simulation and population pharmacokinetics.
•Good understanding of biostatistics, experienced in data handling, process and analysis
•Able to take directives and work independently
•Excellent interpersonal skills
•Manage and prioritize multiple programs with competing and aggressive time lines with supervision.
•Support the Preclinical Pharmacokinetics department as needed.