Associate Director, Biostatistics

Job Summary:

The Associate Director, Biostatistics provides statistical leadership for assigned clinical development programs, including study design, analysis planning, and statistical reporting in support of clinical trial execution and regulatory submissions. Serves as the lead statistician on cross-functional study teams, shaping protocol design, sample size and power considerations, and analysis strategy from early development through submission. Oversees the quality and timeliness of statistical deliverables, whether produced internally or through CRO partners, and ensures all outputs meet ICH and regulatory expectations. This role requires both deep statistical expertise and the ability to communicate complex quantitative concepts clearly to clinical, regulatory, and executive audiences.

Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week, currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

Serve as lead statistician for one or more clinical studies, from protocol design through clinical study report.

Develop statistical analysis plans (SAPs), sample size/power calculations, and randomization schemes.

Oversee production and QC of tables, listings, and figures (TLFs) performed internally or by CROs.

Collaborate with Clinical, Regulatory, and Data Management on study design, protocol development, and data review.

Contribute statistical input to regulatory submissions, briefing documents, and health authority responses.

Review and provide statistical input on clinical study reports and publications.

Ensure statistical deliverables comply with ICH guidelines and applicable regulatory standards.

Perform other duties and responsibilities as assigned

Qualifications:

Education: PhD in Biostatistics, Statistics, or a closely related quantitative discipline required.

5 years of biostatistics experience in pharmaceutical, biotechnology, and/or CRO settings preferred.

Experience in immunology, inflammation, or a related therapeutic area preferred.

Advanced proficiency in SAS and/or R for statistical analysis and programming.

Strong knowledge of clinical trial design and operation, ICH E9 principles, and CDISC ADaM standards.

Experience with adaptive trial designs, interim analyses, and Bayesian or frequentist methods as applicable.

Experience with CRO statistical oversight and governance, including statistical deliverable review, CRO quality management, and the establishment of biostatistics standards within a virtual or outsourced development model.

Ability to lead statistical strategy discussions with cross-functional and external stakeholders.

Sound scientific judgment in interpreting and communicating complex statistical results.

Ability to translate statistical concepts for non-statistician audiences, including regulatory agencies.

Effective at presenting statistical findings to program teams and senior leadership.

Skilled at collaborating cross-functionally with Clinical, Regulatory, and Data Management colleagues.

Salary Range:

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$181,000, $235,000 USD