Associate Principal Scientist Statistical Programming- Oncology, PKPD- Hybrid

Job Description

Responsibilities:

This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders spanning all therapeutic areas.  The programming analyst will gather and interpret user requirements, retrieve the required data, transform the data into modeling-ready analysis datasets, and develop tables and figures according to the modeling analysis plans.   The programming analyst will take on a data stewardship leadership role and be accountable for the creation of modeling data from original data source(s) to final modeling dataset.  The programming analyst will be a key collaborator with modelers, statisticians and other project stakeholders and is expected to execute project plans efficiently and oversee the work of other team members when opportunities arise.

Primary Activities:

• Programmatically synthesize clinical / preclinical data into analysis ready structures from varied data sources
• Create modeling-ready datasets by integrating PK, ADA, PD and covariate data
• Produce tables and graphics for inclusion in study reports and regulatory submissions
• 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
• produce SAS transport files and associated documentation for regulatory submissions
• Represent statistical programming on process improvement activities

Education and Minimum Requirement:

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

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

Department Required Skills and Experience:

• Excellent interpersonal skills and ability to negotiate and collaborate effectively
• Excellent written, oral, and presentation skills
• Broad knowledge and significant experience in developing analysis and reporting deliverables for Research and Development projects (data, analyses, tables, graphics, listings)
• Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders

Position Specific Required Skills and Experience:

• 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
• 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).

** Preferred Skills and Experience:

• Familiarity with pharmacokinetics modeling and simulation datasets and analyses
• Experience with at least one other software than SAS (e.g., R, Splus, NonMem)
• Good working knowledge of reporting processes (SOPS) and software development life cycle (SDLC)
• Utilizes and contributes to the development of standard departmental SAS macros
• Ability and interest to work across cultures and geographies
• Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
• Active in professional societies

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