Associate Director of Biostatics
Associate Director of Biostatistics
Hybrid (Must be based in the US)
Compensation: $144,000-$216,000 + Bonus
Company Summary:
We are working with a leading biopharmaceutical organization focused on developing innovative inhaled therapeutic products and devices to address serious unmet medical needs in endocrine and orphan lung diseases. Their proprietary technologies enable rapid, convenient delivery of medicines to the deep lung, improving outcomes for conditions such as diabetes, pulmonary fibrosis, pulmonary hypertension, and rare lung infections. This is a mission-driven team committed to advancing science and improving patient lives.
Role Overview:
The Associate Director of Biostatistics will lead statistical design, analysis, and regulatory strategy across multiple clinical programs. Acting as the lead statistician on several studies, this role combines technical depth with cross-functional leadership and offers the opportunity to make a significant impact in a fast-paced, high-growth environment.
Primary Responsibilities:
- Provide statistical input on protocol design, endpoints, estimands, and sample size calculations
- Develop randomization plans and collaborate on system implementation
- Author Statistical Analysis Plans and oversee TLF development
- Review and approve CSRs, submission packages, and regulatory deliverables
- Partner with programmers on dataset specifications (SDTM, ADaM)
- Support publications and regulatory submissions, including Agency meetings
- Manage CROs and contract statisticians
- Ensure compliance with GCP, FDA, and global regulatory standards
Ideal Qualifications:
- MS or PhD in Statistics, Biostatistics, or related discipline
- 10+ years of experience in clinical trial biostatistics (pharma or biotech)
- Proficiency in SAS and statistical programming
- Strong understanding of regulatory requirements and CDISC standards
- Excellent communication and cross-functional collaboration skills
- Ability to act independently and manage multiple projects
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