Clinical Research Statistician

2 weeks ago


Philadelphia, Pennsylvania, United States ACE Partners Full time

Key Responsibilities



  • Study Design & Statistical Planning: Collaborate with clinical teams to design studies, including sample size calculations, randomization plans, and statistical methodology to ensure scientifically sound trials.
  • Statistical Analysis: Perform and oversee statistical analyses of clinical trial data, ensuring adherence to regulatory standards and industry best practices.
  • Data Interpretation: Work with clinical teams to interpret statistical results and provide insights to support clinical conclusions.
  • Statistical Programming: Develop, validate, and maintain statistical programs using SAS or other software to support data analysis and reporting.
  • Regulatory Support: Prepare statistical sections of clinical trial protocols, statistical analysis plans (SAPs), and contribute to regulatory submissions.
  • Collaboration & Communication: Provide statistical input to cross-functional teams and communicate statistical findings clearly to stakeholders.
  • Quality Assurance: Ensure data integrity and accuracy, conduct quality control checks, and adhere to Good Clinical Practice (GCP) guidelines and SOPs.

Qualifications



  • Education: Master's or Ph.D. in Biostatistics, Statistics, or a related field.
  • Experience: 3+ years of experience in clinical trial biostatistics, preferably within a CRO or pharmaceutical setting.
  • Technical Skills: Proficiency in statistical software such as SAS, R, or similar tools. Experience with CDISC standards (SDTM, ADaM) is preferred.
  • Regulatory Knowledge: Familiarity with FDA, EMA, and ICH guidelines as they relate to statistical practices in clinical research.
  • Communication Skills: Ability to communicate complex statistical concepts to stakeholders.
  • Team-Oriented: Ability to work effectively in a collaborative team environment.

Benefits



  • Competitive salary and benefits package.
  • Flexible work schedule.
  • Opportunities for career growth and continuing education.


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