Job Description

Job Description

Job Description

Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates

Overview: We are seeking a highly skilled Biostatistician to support DMCs/DSMB, IRT specifications, and manual randomization (coding). This role involves presenting statistical results during closed DMC/DSMB sessions and ensuring the integrity of unblinded data throughout clinical trials. The ideal candidate will have experience in handling open and closed session meetings, managing unblinded datasets, and working within regulated environments.

Key Responsibilities:

• Prepare and analyze unblinded data for interim analyses and safety reviews
• Develop statistical reports and presentation materials for closed DMC/DSMB sessions
• Present unblinded findings to DMC/DSMB members in a confidential manner
• Ensure regulatory compliance and maintain blinding integrity outside closed sessions
• Develop IRT specifications to manage randomization and drug supply logistics.
• Program and validate manual randomization schedules using statistical coding (e.g., SAS, R, or other tools).
• Troubleshoot and ensure accuracy in IRT and randomization implementation.
• Conduct safety and efficacy analyses in alignment with trial protocols.
• Work closely with clinical and regulatory teams to provide statistical insights.
• Document statistical methodologies and ensure compliance with GCP, ICH, and regulatory standards.

Qualifications:

• Master’s or Ph.D. in Biostatistics, Statistics, or a related field.
• Prior experience as an unblinded statistician in clinical trials.
• Strong understanding of DMC/DSMB procedures and regulatory expectations.
• Hands-on experience with IRT systems and manual randomization.
• Proficiency in statistical programming (e.g., SAS, R).
• Ability to interpret and present complex statistical results to non-statisticians.
• Strong communication and ability to maintain confidentiality in unblinded roles.
• Detail-oriented with excellent problem-solving skills.
• Ability to manage varying workloads efficiently (~20 hours per week)

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