Director, Biostatistics
Ladders · United States · 1 mo ago
RemoteRemoteAnalyst$221k–$273k/yrFull-time
Responsibilities
- Lead regulatory interactions and filing efforts to ensure statistical integrity
- Oversee study design and sample size determination; author and review key statistical documentation
- Collaborate with biometrics and cross-functional teams to meet project timelines
- Maintain statistical integrity in deliverables by ensuring sound methodologies
- Conduct independent analyses and propose novel statistical approaches
- Develop departmental standards and contribute to advanced statistical research
- Mentor junior team members and support their professional growth
Qualifications
- PhD in Statistics or Biostatistics with 8+ years of experience in clinical trials within the pharmaceutical industry
- Proven experience in NDA/BLA/MAA activities and regulatory interactions from a statistical perspective
- Prior experience as a product lead statistician in cross-functional teams
- Skilled in developing Statistical Analysis Plans (SAP) and TFL specifications
- Familiarity with ICH guidelines, regulations from FDA/EMA, and statistical analysis of longitudinal data
- Detail-oriented with strong organizational and problem-solving skills
- Proficient in SAS and R, with knowledge of CDISC standards including SDTM and ADaM
Benefits
- Generous vacation time and company-observed public holidays
- Provided volunteer days for community service
- Long-term incentives and employee stock purchase plans available
- Comprehensive employee wellbeing benefits
- Fitness reimbursement to support healthy lifestyles
- Tuition sponsoring for ongoing education and development
- Professional development plans to foster career growth