What are the responsibilities and job description for the Senior Biostatistician position at Princeton Pharmatech?
Princeton Pharmatech is a specialized provider of biostatistics and programming solutions to the pharmaceutical, biotechnology, life science industries and research institutions worldwide. With headquarters in Princeton, New Jersey and San Francisco, CA, we have provided biostatistics and programming solutions in various therapeutic areas leading to IND and NDA submissions in the US, Europe, and Japan. We are seeking an experienced Senior Biostatistician to be a key member of clinical study teams responsible for the development of statistical analyses contributing to the submission from client-sponsored clinical studies. Our ideal candidate will provide leadership and guidance on designing studies, statistical methods, analyses, interpretation, and reporting of the clinical study results. Also, possess a strong work ethic capable of adjusting to multiple demands and shifting priorities.ResponsibilitiesServes as lead statistician for assigned projects to provide statistical and programming support in one or more Phase I-III clinical studies.Ownership of planning and design of clinical studies.Create statistical and strategic input in the writing of Statistical Analysis Plans (SAP).Design and perform quality checks on analysis datasets, tables, listings, figures (TFL), and written reports to support clinical trial results using SAS.Review case report forms (CRF) and other related study documents.Validate statistical deliverables and ensure that appropriate statistical methods are utilized.Present in clinical study team meetings and deliver statistical input clearly.Consult with clients regarding study protocol or statistical analysis issues.Communicate statistical information to non-scientists and present results.Ensure adherence to industry standards and regulatory requirements.Facilitate the development and application of adequate statistical methods in clinical research.RequirementsPhD or MS degree in Statistics, Biostatistics or related field.5 years of relevant work experience in CRO, biotech, pharmaceutical, or life sciences industry.Familiarity with clinical trial design and analysis activities and knowledge of regulatory guidelines (FDA / EMA, ICH / GCP).Experience with NDA / BLA submission activities.Experience in statistical programs such as Statistical Analysis System (SAS), SAS Base, SAS Macro, SAS / STAT, SAS / Graph, ODS, CDISC, and SDTM.Maintain awareness of industry standards, regulatory requirements, departmental guidelines, and Standard Operating Procedures (SOPs).Excellent organizational skills, time management, ability to prioritize workload, and meet deadlines.Excellent communication and interpersonal skills to effectively interact with others.Job Category : Senior BiostatisticianJob Type : RemoteJob Location : Princeton#J-18808-Ljbffr
