Lead Biostatistician, Clinical Development

EmergencyMD; Morristown (NJ); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Altimmune is seeking a senior statistician to serve as lead statistician for one or more clinical development programs. You will collaborate with clinical teams to plan, conduct, and analyze studies across all phases, ensuring quality of statistical design and data reporting.

You will interact with regulators, external vendors, and cross-functional teams, applying rigorous statistical methods and driving methodology innovations in a high-impact environment.

Qualifications

• PhD in Statistics, Biostatistics, or related field with 7+ years of experience or MS with 10+ years of equivalent industry experience.
• Strong knowledge of statistical methods for clinical trials including longitudinal data, survival analysis, and Bayesian approaches.
• Experience with regulatory interactions and FDA/EMA expectations for statistical evidence.
• Proficiency in SAS and/or R; extensive CDISC SDTM/ADaM experience.
• Excellent communication and leadership abilities; ability to explain complex stats to non-statisticians.

Responsibilities

• Serve as the lead statistician for clinical development programs across phases.
• Provide statistical input into study design, estimands, and analysis methodologies.
• Oversee analyses for interim results, database locks, top-line results, and CSRs.
• Collaborate with vendors, CROs, and regulatory agencies as needed.

Skills

Statistical leadership

SAS & R

CDISC SDTM/ADaM

ICH-GCP compliance

Regulatory submissions

Communication skills

Team leadership

Education

PhD in Statistics/Biostatistics

MS in related field

Tools

SAS

R

CDISC tooling

Job description

Altimmune is seeking a senior statistician to serve as lead statistician for one or more clinical development programs. You will collaborate with clinical teams to plan, conduct, and analyze studies across all phases, ensuring quality of statistical design and data reporting.

You will interact with regulators, external vendors, and cross-functional teams, applying rigorous statistical methods and driving methodology innovations in a high-impact environment.