Purpose:

The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products.

The Senior Statistical Analyst of CPPM programming independently performs programming activities for complex, heterogeneous assets and closely communicates with pharmacometricians and clinical pharmacologists.

The Senior Statistical Analyst works on improving existing workflows and mentors Statistical Programmers and Statistical Analysts.

Responsibilities:

•Create datasets for pharmacokinetic and pharmacodynamic studies for NONMEM and PK/PD analyses

•Consolidate heterogeneous data sources (e.g. clinical study databases, external databases, real-world data) to prepare analysis-ready data sets within a defined quality control process supporting a particular project, study or asset deliverable

•Independently perform programming activities for complex, heterogeneous assets

•Improve the efficiency and quality of existing workflows for the provision of data sets and scientific contributions

•Perform exploratory data analyses and visualizations in interaction with the clinical pharmacologist or pharmacometrician

•Produce dynamic and static data visualizations in SAS or R to communicate quantitative analyses

•Work with international and interdisciplinary teams

•Leads the development of standard SAS Macros and participates in the development of standard operating procedures.

•Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.

This role can be hired as a Sr. Statistical Analyst or Statistical Analyst, dependent on years of relevant experience; previous work, education, training, and clinical research capabilities.

Qualifications for Sr. Statistical Analyst:

•MS in Statistics, Computer Science or a related field with 6+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 8+ years of relevant experience.

•Indepth understanding of SAS programming concepts and techniques related to drug development.

•Fundamental understanding of CDISC Standards.

•Fundamental understanding of the drug development process, including experience with regulatory filings.

•Ability to communicate clearly both oral and written.

•Ability to accurately estimate effort required for study related programming activities.

•Programming experience in R is desirable

Key Stakeholders:

• clinical pharmacologist • pharmacometrician • Data Scientists

Qualifications for Statistical Analyst:

• MS in Statistics, Computer Science or a related field with 3+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 5+ years of relevant experience.
• High degree of technical competence and communication ability, both oral and written. Competent in SAS programming and Macro development.
• Pharmaceutical or related industry experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.
• Demonstrated practical understanding of SAS programming concepts and techniques appropriate to pharmaceutical industry. Demonstrated satisfactory ability to apply SAS programming knowledge to solve problems related to non-routine situations.
• Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications.
• Expertise in the use of UNIX utilities and SAS Macros
• Ability to work collaboratively with others to develop quality CRFs, databases, reports, publications and regulatory submission.
• Ability to appropriately delegate assignments and review deliverables so that projects are delivered on time with suitable quality.
• Ability to identify opportunities for productivity improvements and formulate implementation plans.
• Ability to contribute to the determination of project standards related to output design and statistical programming conventions, and, with supervision ensures they are appropriate to support project objectives.