Associate Principal Scientist Statistical Programming- Oncology, PKPD- Hybrid
USA - Pennsylvania - North Wales (Upper Gwynedd)
Job Description
Responsibilities:
This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders spanning all our company's 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 preclinical / clinical data into analysis ready structures from varied data sources
Create modeling-ready datasets by integrating PK, ADA, PD and covariate data
Produce tables, listings 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 9-12 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 &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 …
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Hybrid Hybrid work model
Benefits/PerksFlexible work arrangements Hybrid work Insurance Meetings Paid holidays Retirement benefits Sick Days Vacation
Tasks- Collaboration
- Collaboration with stakeholders
- Leadership
- Presentation
- Process Improvement
- Project management
- Reporting
Algorithms Analysis Business Operations Collaboration Data manipulation Data preprocessing Engineering Innovation Interpersonal Leadership Manufacturing Mathematics Oncology Presentation Process Improvement Project Management Quality R Regulatory Submissions Reporting Research SAS SAS programming SDLC Software Development SOPS Statistical methods Statistical Programming Statistics
Experience7 years
EducationApplied mathematics BA/BS BA/BS in Computer Science Business Computer Science Engineering Life Sciences Management Mathematics MS MS in Computer Science Related Field Science Statistics
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Europe/London Pacific/Honolulu UTC+0 UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9