Sr. Scientist, Statistical Programming- PKPD Oncology & Biomarkers; Hybrid

Overview

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the-art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics. The senior statistical programmer will gather and interpret user requirements for analysis and programming requests in close collaboration with statistical and clinical colleagues, retrieve the required data, and then transform the data into analysis datasets for further statistical analysis and reporting needs. The senior programmer will partner with statisticians to solve problems;

reduce the amount of programming tasks being completed by statisticians to facilitate an increase in efficiency and compliance for statistical analyses. The senior programmer will also write programs to analyze data with statistical methods which are not currently available through commercial software packages.

• Pre-process, filter, and manipulate complex data for the analyses of molecular biomarker data, imaging data, and external data other than traditional laboratory data

• Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses

• Create modeling-ready datasets by integrating PK, PD and covariate data

• Prepare compliant programming code for regulatory submissions including analysis datasets, tables, listings, figures, SAS transport files and associated documentation

• Ensure programmatic traceability from data source to modeling result

• Support the development of programming standards to enable efficient and high-quality production of programming deliverables

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS programming experience in a clinical trial environment

• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS programming experience in a clinical trial environment

• Effective interpersonal skills and ability to negotiate and collaborate effectively

• Effective written, oral, and presentation skills

• Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)

• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders

• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH

• Designs and develops complex programming algorithms

• Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical or pharmacokinetic terminology and concepts;

• Implements statistical methods not currently available through commercial software packages.

• Demonstrated ability to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements, knowledge of pharmaceutical development processes.

• Familiarity with clinical pharmacology concepts

• Experience with at least one other software than SAS (e.g., R, Python, Splus, Non Mem)

• Efficiently manipulates clinical trial datasets including complex data preprocessing, filtering, and manipulation; programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).

• Experience / knowledge on applying ML/AI methods to enhance data preprocessing, analysis and reporting.

• Good working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)

• Utilizes and…