Job Description

We have a current opportunity for an AD Biostatistics - Oncology Role on a permanent basis with a leading Oncology pharma company. This position can be remote. This incumbent must have oncology pharma industry experience in clinical trials to be considered. For further information about this position please apply.

Job Title: Associate Director, Biostatistics (Oncology)

Location: New Jersey | remote

Job Type: Full-time

Job Overview: The Associate Director of Biostatistics (Oncology) will lead complex studies in study design and statistical analysis. This role involves collaborating with cross-functional teams to design, analyze, and interpret clinical studies, ensuring the highest quality and compliance with regulatory standards. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses.

Key Responsibilities:

• Clinical Trial Design: Collaborate with clinical investigators to design oncology trials with appropriate statistical methods and sample sizes.
• Statistical Analysis Plans: Develop and review statistical analysis plans (SAPs) to capture design elements and statistical methodologies.
• Data Analysis: Perform statistical analyses, validate results, and ensure accuracy and quality of deliverables.
• Regulatory Submissions: Provide statistical input for clinical development plans, study protocols, clinical study reports, and regulatory submission documents.
• Cross-functional Collaboration: Represent the biostatistics function in cross-functional teams, providing strategic input and guidance.
• Mentorship: Mentor and guide less experienced biostatisticians and statistical programmers.
• Quality Assurance: Oversee outsourced statistical activities and ensure deliverables meet high-quality standards.
• Innovation: Identify and implement innovative statistical approaches to improve study designs and outcomes.

Qualifications:

• Education: PhD or Master's degree in Biostatistics, Statistics, Mathematics, or a related field.
• Experience: Minimum of 5 years (8 years for Master's) in the pharmaceutical industry or CRO, with at least 3 years of leadership experience in oncology trials.
• Skills: Proficiency in statistical analysis software (SAS or R), sample size calculation software and advanced statistical methods (adaptive design, Bayesian methods).
• Knowledge: Strong understanding of clinical development, regulatory guidelines (ICH, FDA, EMA)
• Communication: Excellent communication skills, with the ability to express complex analyses clearly and effectively.
• Teamwork: Ability to work collaboratively in a multidisciplinary team and drive high-quality results.

Benefits:

• Competitive salary and benefits package.
• Opportunities for professional development and career growth.
• Collaborative and innovative work environment.

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