Senior Biostatistician

Company: Princeton Pharmatech
Location: Princeton
Posted on: February 25, 2021

Job Description:

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 experiencedSenior Biostatisticianto 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.Responsibilities

• Serves 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 reports 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 researchRequirements
  • PhD 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 (SOP's)
  • Excellent organizational skills, time management, ability to prioritize workload, and meet deadlines
  • Excellent communication and interpersonal skills to effectively interact with othersApply -jobs@princetonpharmatech.com Upload CV/Resume * Allowed Type(s): .pdf, .doc, .docx By using this form you agree with the storage and handling of your data by this website. * About Us Princeton Pharmatech provides Data Programming and Biostatistical services. In the last 10 years we have made it our MISSION to deliver information in a timely and accurate manner at a reasonable cost.
    Our TEAM of experts pride themselves in getting the results for all phases in your CLINICAL DEVELOPMENT. Our GOAL is to be your PREFFERED VENDOR for all your CLINICAL STUDIES for the future!

Keywords: Princeton Pharmatech, Trenton , Senior Biostatistician, Other , Princeton, New Jersey