Director, Biostatistics (Remote - US)

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Biostatistics in the United States.

The Director of Biostatistics will provide strategic leadership for pharmacokinetic (PK) and pharmacodynamic (PD) studies across all phases of clinical development. This role partners with cross-functional teams to ensure robust study design, insightful analysis, and timely regulatory support. You will oversee statistical planning, modeling, and interpretation to guide clinical decisions, ensuring high-quality, compliant, and efficient execution. The position requires expertise in PK/PD methodologies, regulatory interactions, and strong collaboration skills with internal and external stakeholders. This is an opportunity to influence clinical development strategy, mentor emerging talent, and contribute to advancing therapies in complex therapeutic areas such as oncology, immunology, or inflammation.

Accountabilities

·         Provide strategic biostatistical leadership for PK/PD studies across clinical development programs.

·         Collaborate with clinical pharmacology teams to design studies addressing PK, ADME, bioavailability, and drug–drug interactions.

·         Develop, review, and oversee statistical analysis plans (SAPs) for PK/PD endpoints.

·         Conduct or supervise exploratory exposure–response analyses, covariate modeling, and data visualization to inform clinical and regulatory strategy.

·         Ensure accurate, compliant, and timely statistical contributions to regulatory submissions (e.g., INDs, NDAs, BLAs).

·         Communicate complex statistical concepts and results effectively to both technical and non-technical audiences.

·         Partner with internal teams, CROs, and external consultants to align on study design, analysis, and reporting.

·         Establish and refine SOPs, work instructions, and best practices for PK/PD data analysis.

·         Mentor junior statisticians and contractors, fostering professional growth and technical excellence.

·         Master’s degree with 7+ years’ relevant experience, or Ph.D. with 5+ years’ experience in biostatistics or related field.

·         Expertise in pharmacokinetics, pharmacodynamics, and statistical modeling for clinical studies.

·         Strong experience with non-compartmental and population PK analysis.

·         Demonstrated ability to work collaboratively with cross-functional teams and external partners.

·         Proficiency in SAS programming and statistical software used in clinical development.

·         Experience with regulatory submissions and interactions with agencies.

·         Excellent analytical, problem-solving, and communication skills.

·         Prior experience in oncology, immunology, or inflammation therapeutic areas preferred.

·         Commitment to fostering teamwork, providing actionable feedback, and continuous learning.

·         Competitive annual salary: $180,200 – $240,200.

·         Eligibility for annual bonus or incentive compensation plans depending on role.

·         Discretionary equity awards and opportunity to participate in the Employee Stock Purchase Plan.

·         Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs.

·         Opportunities for professional growth, mentorship, and leadership development.

·         Inclusive, collaborative, and mission-driven work environment.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest!

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