Biostatistician

Biostatistician

Philadelphia, PA

Clinical Research Organization (CRO)

Full-Time

$74,000 - $118,000

We are seeking a talented Biostatistician to join our growing team. The ideal candidate will work closely with clinical operations, data management, and regulatory teams to ensure the statistical integrity and accuracy of our clinical trials. You will play a crucial role in all phases of clinical trials, from design and planning to analysis and reporting, ensuring the success of our clients' projects.

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 (e.g., FDA, EMA).
• Collaboration & Communication: Provide statistical input to cross-functional teams and communicate statistical findings clearly to both technical and non-technical 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: Strong ability to communicate complex statistical concepts to non-statistical stakeholders, both verbally and in writing.
• Team-Oriented: Ability to work effectively in a collaborative, cross-functional team environment.

Benefits

• Competitive salary and benefits package.
• Flexible hybrid work schedule (remote and on-site).
• Opportunities for career growth and continuing education.