Associate Director Biostatistics

The Lotus Group LLC; United States; Remote; USD 130,000 - 160,000; Full time

Job summary

A leading biotechnology firm is seeking an Associate Director of Biostatistics for a remote position. This role focuses on providing statistical leadership for a major regulatory filing and collaborating with cross-functional teams. The ideal candidate should have a PhD in Biostatistics and over 5 years of relevant industry experience. Responsibilities include overseeing statistical strategy and analyses for clinical trials. This opportunity allows for direct impact on critical projects while working within a supportive team environment.

Qualifications

• 5+ years of industry experience within pharmaceutical or biotech companies.
• Demonstrated experience supporting late-stage development and regulatory filing.
• Ability to manage multiple priorities effectively.

Responsibilities

• Serve as the statistical lead for an upcoming filing.
• Lead statistical strategy for clinical trials and analysis plans.
• Oversee statistical analyses for regulatory submissions.
• Collaborate with various teams to ensure quality standards.
• Contribute to best practices within the Biostatistics function.

Skills

Statistical leadership

Clinical trial methodology understanding

Regulatory expectations knowledge

Strong communication skills

Ability to influence cross-functionally

Independent work in a remote environment

Education

PhD in Biostatistics or a related quantitative field

Job description

Remote – United States (EST/CST/MST/PST)

Upcoming Regulatory Filing Support

Our client, an innovative biotechnology company preparing for a major upcoming regulatory filing, is seeking an Associate Director of Biostatistics to join their growing team. This is a fully remote role open to candidates based anywhere in the United States.

The Associate Director will provide statistical leadership for a late-stage program, partnering cross‑functionally to ensure high‑quality statistical strategy, study design, and deliverables that support the filing. This role is well‑suited for someone who enjoys meaningful ownership, collaborative work, and contributing directly to a submission.

Key Responsibilities

• Serve as the statistical lead for an upcoming filing, ensuring scientific and regulatory rigor across all deliverables.
• Lead statistical strategy for clinical trials, including study design, analysis plans, sample size justification, and endpoint selection.
• Oversee statistical analyses to support clinical development, regulatory submissions, and responses to health authorities.
• Collaborate closely with Clinical Development, Regulatory, Programming, and Data Management teams.
• Provide guidance to internal teams and external partners to ensure timelines and quality standards are met.
• Contribute to ongoing process improvements and best practices within the Biostatistics function.

Qualifications

• PhD in Biostatistics or a related quantitative field required.
• 5+ years of industry experience within pharmaceutical or biotech companies.
• Demonstrated experience supporting late‑stage development; regulatory filing experience strongly preferred.
• Solid understanding of clinical trial methodology, regulatory expectations, and statistical principles.
• Strong communication skills with the ability to influence and collaborate cross‑functionally.
• Ability to work independently in a fully remote environment while managing multiple priorities.

Why This Opportunity

• Direct impact on a near‑term filing and high‑visibility program.
• Fully remote role with national flexibility.
• Ability to join a collaborative team with strong leadership support.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Research, Analyst, and Project Management

Industries

Biotechnology Research and Pharmaceutical Manufacturing