8913859 Statistical Programmer Analyst II
1 year Contract in South San Francisco.
A strong candidate can work remotely in US.
The Clinical Pharmacology (CP) Modeling and Simulation Analyst (M&S Analyst) sits in the Modeling and Simulation (M&S) Group within the Clinical Pharmacology Department and is responsible for the programming support for analysis-ready datasets as well as graphical and tabular outputs.
These datasets will be used for non-compartmental analyses as well as pharmacometric M&S analyses. These datasets generally integrate patient, dosing, drug concentration, pharmacodynamic responses, clinical efficacy, and safety information from clinical studies.
Daily responsibilities typically include dataset planning, designing, developing, graphical evaluation, QC, regulatory submission, reporting of non-compartmental and M&S datasets and simple M&S analyses if applicable.
The M&S Analyst may support internal/external presentation and reporting of data and other sections of M&S analysis plans and results as applicable.
The M&S Analyst may assist or sometimes lead the development of standardization and process optimization for delivery of analysis ready data.
The M&S Analyst may also contribute to departmental initiatives such as literature database access, pharmacogenomics database access, real world data access, system infrastructure, software/tool development and other efforts.
All of the above will be accomplished by working in close partnership with Clinical Pharmacology, Clinical Programming, Clinical Data Management, quality control teams, regulatory, and study management teams.
Highly proficient in a statistical programming language such as SAS, R, Python, or S-Plus.
Preference will be given to candidates with combined SAS and R skills.
Experience working with clinical pharmaceutical data and CDISC standards.
Experience in data pooling and graphical representation of clinical trial data is highly desired.
Knowledge of the drug development process, clinical data systems, and global regulatory standards is preferred.
Experience with M&S datasets, methodologies, and software (such as NONMEM and WinNonLin) is preferred, but not required.
Strong analytical, organization, and communication skills, attention to detail, as well as working effectively in a multidisciplinary team setting are essential.
The M&S Analyst must be open-minded, flexible, and ready to learn new concepts and tools.
M.S. or B.S. in Statistics, Mathematics, Engineering,
Data Science or related discipline with 1+ year of experience for M.S. or 2+ years for B.S.