Associate Director BiostatisticsThe Lotus Group LLC • Saint Paul, Illinois, United States
Associate Director Biostatistics
The Lotus Group LLC
- Saint Paul, Illinois, United States
- Saint Paul, Illinois, United States
Über
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
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Sprachkenntnisse
- English
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