Principal Scientist, Stat. Programming- Eary Oncology Development; Hybrid

Overview

Statistical Programming is in the Biostatistics and Research Decision Sciences (BARDS) department at our company's Research & Development Labs which supports the targeting, discovery, development, manufacturing, and marketing of drugs and vaccines for the benefit of patients and global public health.

This position focuses on strategic activities impacting early stage development projects to the direct benefit of project teams and the Biostatistics organization. The principal statistical programmer will partner with statisticians to solve problems; reduce the amount of programming task being completed by statisticians to facilitate an increase in efficiency and compliance for statistical analyses. The incumbent will write programs to analyze data with statistical methods which are not currently available through commercial software packages.

The position is a key collaborator with internal and external stakeholders including Statistics, Clinical Research, Data Management, Regulatory, Clinical Safety, and PK/PD Modeling and Simulation organizations.

• Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses
• Address operational challenges that require strategic solutions across early oncology development
• Support the development of programming standards to enable efficient and high quality production of programming deliverables
• Facilitate global adoption of standards and programming best practices within the early oncology space
• Pre-process, filter, and manipulate complex data for the analyses of molecular biomarker data, imaging data, and external data other than traditional laboratory data
• Lead and actively contribute to departmental strategic initiative project teams

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 12 years SAS/R programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 10 or more years SAS/R programming experience in a clinical trial environment

• Excellent interpersonal skills and ability to negotiate and collaborate effectively
• Excellent written, oral, and presentation skills
• Superior knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
• Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders

• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
• Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) according to quality, compliance and timeliness requirements
• Designs and develops complex programming algorithms
• Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; implements statistical methods not currently available through commercial software packages
• Thrives in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes
• Efficiently manipulates very large databases including complex data preprocessing, filtering, and manipulation
• Experience in CDISC and ADaM standards
• Demonstrated success in the assurance of deliverable quality and process compliance
• Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions
• Ability to anticipate stakeholder requirements
• Ability and interest to work across cultures and geographies

• Experience with early oncology development
• Experience developing and implementing statistical programming standards
• Experience in process assessment, improvement and operational excellence methodologies
• Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
• Experience developing and managing a project plan using Microsoft Project or similar package
• Active in professional societies
• US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables
• Solid knowledge and experience on oncology clinical trial concepts and standards

• Data Management
• Datasets
• Oncology