Associate Director Biostatistics

The Company:

Late-stage autoimmune company focused on developing and commercializing small molecule therapies.

The full-time Associate Director of Biostatistics is a skilled biostatistician who can work independently as the study statistician Phase 1-2 studies and under the direction of a Director of Biostatistics, or above, as the study statistician for Phase 3 studies. This person specializes in creating clinical study designs, performing data analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions.

In addition, this person provides statistical input to study designs and can contribute to departmental or cross‑functional initiatives to enhance business processes and improve efficiency.

• Serve as a study statistician for assigned clinical studies related to one or more clinical programs.
• Provide statistically sound experimental design and data analysis strategies to meet project objectives with high quality in a timely manner.
• Provide statistical inputs on clinical development plans.
• Contribute to the development of clinical study protocols and author the statistical sections.
• Develop statistical analysis plans and work with programming to create table, listing and figure shells for clinical trials or ad‑hoc analyses.
• Develop study randomization specification and verification documents as necessary.
• Perform sample size calculations and assess trial design operating characteristics under various assumptions. Advise the team on the most efficient design to meet study objectives.
• Review CRFs and edit checks and participate in UAT of different systems.
• Review dataset programming specifications, key derived variables, and statistical deliverables.
• Independently derive from source data key efficacy variables and analyses.
• Perform the analyses of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to the clinical study reports, clinical publications, conference posters and presentations.
• Review and contribute to study and project timeline and provide high quality statistical deliverables in a timely manner.
• Provide statistical leadership in clinical study team setting.
• Manage in‑house and/or outsourced biostatistical activities and manage biostatistics vendors and contractors as necessary.

• Master's Degree or higher in Statistics, Biostatistics, or closely related field.
• 7+ years for Master’s degree and 5+ years for Ph.D. degree for experience in a drug‑development environment.
• Knowledge of pharmaceutical and regulatory requirements, procedures, and policies.
• Knowledge of GCP, ICH, and other Guidance documents and policies related to clinical trials operations requirements.
• Proficiency in SAS software packages. Knowledge of CDISC requirements.
• Ability to program and oversee programming work performed by programming staff or vendors.
• Demonstrated ability to handle high volumes of work in a fluid, dynamic, and fast‑paced environment.
• Demonstrated ability to work simultaneously on multiple projects, and to deliver high‑quality work according to tight timelines.
• Excellent interpersonal, reading, writing, and communication skills, along with exceptional organizational skills.
• Strong problem and conflict‑resolution skills.
• Travel up to 10%.

Title and compensation will be commensurate on candidate experience. We offer a competitive base, annual bonus, and equity.