Sr. Biostatistician

ADARx Pharmaceuticals Inc.•San Diego, CA

11h•Onsite

About The Position

We are seeking a highly motivated and qualified leader to join our Biostatistics Department as a Senior Biostatistician and work as a team lead to drive success. The Senior Biostatistician will provide strategic and hands-on statistical leadership to support the discovery, development, and clinical advancement of RNA-based therapeutics. This role partners closely with cross-functional teams to design, analyze, and interpret complex data across preclinical and clinical programs, ensuring scientific rigor and regulatory compliance throughout the drug development lifecycle.

Requirements

PhD or MS in Biostatistics, Statistics, Mathematics, or a related quantitative field.
5+ years of biostatistics experience in the pharmaceutical or biotechnology industry.
Direct experience supporting RNA-based therapeutics (e.g., siRNA, mRNA, antisense oligonucleotides).
Strong understanding of drug development processes, including preclinical and clinical trial design.
Proficiency in statistical programming and analysis tools (e.g., SAS, R).
Experience working with CROs and managing outsourced statistical activities.
Knowledge of regulatory guidelines (ICH, FDA, EMA) and submission requirements.
Excellent written/verbal communication, collaboration, and problem-solving skills are essential for this role.
Must be able to work independently with supervision as needed.
Must be collaborative, work well with other team members in a matrix team environment.
Strong organizational skills with attention to detail and accuracy.
Ability to maintain a high level of confidentiality and exercise discretion.
Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges.
Understand project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.

Nice To Haves

Experience with early-phase clinical trials and translational medicine.
Familiarity with bioinformatics or omics-related data analysis.
Prior involvement in regulatory interactions or submissions.
Demonstrated leadership or mentoring experience.

Responsibilities

Lead statistical strategy, study design, and data analysis for RNA-based programs across discovery, preclinical, and/or clinical development.
Develop statistical analysis plans (SAPs), protocols, and supporting documentation in alignment with regulatory expectations.
Provide statistical expertise for dose-finding, PK/PD modeling, biomarker analysis, and translational studies.
Collaborate cross-functionally with Clinical Development, Biometrics, Bioinformatics, Regulatory, and Discovery teams.
Oversee and review statistical outputs from CROs and external partners, ensuring quality and adherence to timelines.
Perform and interpret advanced statistical analyses using appropriate methodologies for high-dimensional and longitudinal data.
Contribute to regulatory submissions, investigator brochures, clinical study reports, and scientific publications.
Communicate statistical results clearly to both technical and non-technical stakeholders.
Mentor junior statisticians and contribute to best practices within the biostatistics function.