Associate Director, Biostatistics

Job Description

• This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Biostatistics based in the United States. This role sits at the intersection of advanced statistical science and clinical development, supporting innovative oncology programs from early study design through regulatory submission. You will lead and contribute to the development of statistical strategies that shape clinical trial outcomes and inform critical decisions in hematology and oncology research. Working within cross-functional global teams, you will collaborate closely with clinicians, regulatory experts, data management, and statistical programming teams to ensure the integrity and scientific rigor of clinical data. The position plays a key role in designing statistical analysis plans, interpreting complex datasets, and contributing to regulatory documentation and scientific publications. This is a highly collaborative and intellectually rigorous environment where your expertise directly influences the advancement of novel therapies. You will also contribute to methodological innovation and help elevate statistical standards across clinical programs.
• Accountabilities: Lead or support the development of study protocols and statistical analysis plans (SAPs), ensuring alignment with study objectives and regulatory expectations Define and apply appropriate statistical methodologies for the design, analysis, and interpretation of clinical trial data Collaborate with data management and statistical programming teams to ensure high-quality datasets and analysis-ready outputs Perform and oversee statistical analyses of clinical trial data, interpreting results to support study conclusions and regulatory submissions Contribute to clinical study reports (CSRs), regulatory documentation, manuscripts, and scientific presentations Participate in database design and study planning discussions to ensure statistical and analytical requirements are met Provide statistical expertise in response to questions from clinical teams, investigators, and regulatory authorities Support research initiatives focused on innovative statistical methodologies and their application in clinical development Requirements: PhD in Statistics or related quantitative field with at least 5+ years of clinical drug development experience, or a Master’s degree with 8+ years of relevant experience Strong experience in clinical trials, including study design, statistical analysis, and regulatory submission support Proficiency in SAS and/or R for statistical programming and data analysis Solid understanding of regulatory guidelines and clinical development processes Experience in oncology or hematology clinical research is preferred but not required Strong analytical thinking skills with the ability to interpret complex datasets and derive meaningful conclusions Excellent written and verbal communication skills, with the ability to present statistical findings clearly to diverse stakeholders Ability to work independently while also thriving in a collaborative, cross-functional team environment Strong decision-making, problem-solving, and stakeholder management abilities Benefits: Competitive annual base salary ranging from approximately $162,600 to $212,600, depending on experience and location Eligibility for annual bonus programs and performance-based incentive compensation (role-dependent) Equity participation opportunities, including discretionary stock awards and employee stock purchase plan Comprehensive healthcare coverage including medical, dental, vision, and prescription benefits Retirement savings plan (401(k)) with additional financial support options such as FSA/HSA Paid time off, holidays, and wellness-focused employee benefits Life and disability insurance coverage for added financial security Opportunity to contribute to global oncology programs with meaningful patient impact Professional development and continuous learning within a highly scientific and collaborative environment.
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