Senior Statistical Programmer, PK/PD Modeling and Simulation(Hybrid at NJ/PA)

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior Statistical Programmer, PK/PD Modeling and Simulation Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Responsibilities:
This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders spanning all client therapeutic areas. The senior programmer 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 programmer 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 programmer will be a key collaborator with modelers, statisticians and other project stakeholders.

Primary Activities:
• Programmatically synthesize preclinical data into analysis ready structures from varied data sources
• Create modeling-ready datasets by integrating PK, 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

Education and Minimum Requirement:
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 Department

Required Skills and Experience:
• 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

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

The Application