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, Early Stage Development and PK/PD Modeling and Simulation Consultant (Hybrid at PA/NJ) 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. Position Summary Responsibilities : This position provides high quality statistical programming deliverables for global stakeholders in Early Development Statistics and PK/PD Modeling and Simulation spanning all client therapeutic areas except oncology. The senior statistical programmer will gather and interpret user requirements for programming requests, retrieve required data, transform data into analysis/modeling datasets, and develop tables, listings and figures according to statistical/modeling analysis plan. The senior programmer will be a key collaborator with statisticians, modelers, and colleagues in other related function areas. Primary Activities : Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation Ensure programmatic traceability from data source to analysis/modeling result Support the development of programming standards to enable efficient and high-quality production of programming deliverables. Education and Minimum Requirement : BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment Department Required Skills and Experience: · Excellent communication (oral, written) skills, interpersonal skills and ability to negotiate and collaborate effectively · Effective knowledge and experience in developing analysis and reporting deliverables for research and development projects (data, analyses, tables, graphics, listings) · A project leader; completes tasks independently at project level Position Specific Required Skills and Experience: · Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters) · Experience in CDISC SDTM and ADaM standards · 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 terminology and concepts; Implements statistical methods not currently available through commercial software packages. Preferred Skills and Experience: Familiarity with clinical pharmacology concepts and pharmacokinetics concepts 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 The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #Senior #Contract
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