Principal Biostatistician - REMOTE

Proclinical is seeking a remote Principal Biostatistician for a leading CRO.

As a Senior Biostatistician, your role involves ensuring the application of robust statistical methodologies throughout various stages of drug development, from study design and protocol development to analysis and reporting.

Must be eligible to work in the US.

Job Responsibilities:

• Lead statistical oversight for projects within designated drug development programs, ensuring the integrity of statistical methodologies in study design, sample size estimation, analysis planning, modeling, data handling, and reporting.
• Mentor and guide less experienced Biostatisticians and Statistical Programmers assigned to projects, fostering their development, and providing valuable technical insights.
• Offer statistical input during protocol design and development, actively participating in the creation of trial protocols and research proposals.
• Act as a primary biostatistician, collaborating effectively with cross-functional teams to contribute strategically through innovative ideas to drug development and commercialization.
• Review and contribute to clinical data management outputs, including eCRFs, data validation specifications, Data Review Plans, and Data Management Plans.
• Draft Statistical Analysis Plans, Statistical Reports, and methodology sections in Clinical Study Reports, while also peer-reviewing documents prepared by others.
• Perform hands-on statistical analysis and modeling, remaining well-versed in contemporary statistical methodologies and regulatory standards.
• Validate core statistical tables, listings, and figures developed by statisticians and programmers, ensuring precision and completeness.
• Confirm ADaM dataset specifications and oversee quality control activities for ADaM datasets created by team members.
• Provide statistical consultation for the publication of trial results and contribute to abstracts, manuscripts, posters, and presentations.
• Ensure all statistical and programming activities adhere to regulatory requirements and applicable standards.
• Engage with regulatory agencies and support sponsors in new drug applications, serving as a statistical point of contact and ensuring compliance with agency expectations.
• Manage statistical and programming resources, conduct capacity analysis, benchmarking, and maintain relevant documentation.
• Participate in interviewing and evaluating professional applicants to contribute to organizational growth and development.

Skills and Requirements:

• A Ph.D. degree in statistical science, mathematical analysis, or a related field, with a minimum of 7 years of relevant experience; alternatively, a Master's degree in these fields with a minimum of 10 years of relevant experience, showcasing exceptional ability and performance.

If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at +(1) 305-929-0913 or p.bonilla@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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