Associate Director, Biostatistics

BioSpace; Cambridge (MA); Hybrid; USD 181,000 - 235,000; Full time

Job summary

Beeline Medicines in the United States seeks an Associate Director, Biostatistics to provide statistical leadership across clinical development programs, shaping design, analysis plans, and regulatory submissions. You will oversee study design, sample size and analysis strategy from early development through submission.

This role requires deep statistical expertise and the ability to communicate complex quantitative concepts clearly to clinical, regulatory, and executive audiences.

Qualifications

• PhD in Biostatistics or closely related field required.
• Minimum of 5 years biostatistics experience in pharma/biotech/CRO settings preferred.
• Experience with immunology/inflammation or related areas is a plus.

Responsibilities

• Serve as lead statistician for one or more clinical studies from protocol design to study report.
• Develop SAPs, and perform sample size/power calculations and randomization schemes.
• Oversee production and QC of tables, listings, and figures (TLFs) by internal teams or CROs.
• Collaborate with Clinical, Regulatory, and Data Management on study design and data review.
• Contribute statistical input to regulatory submissions and briefing documents.
• Review and provide input on clinical study reports and publications.
• Ensure compliance with ICH guidelines and regulatory standards.

Skills

PhD Biostatistics

5+ years experience

SAS and/or R

ICH E9 knowledge

CDISC ADaM

Adaptive trial designs

CRO oversight

Cross-functional leadership

Education

PhD in Biostatistics

Tools

SAS

R

CDISC ADaM

Job description

About Beeline Medicines

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category‑leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best‑in‑class and first‑in‑disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life‑changing impact. Led by an established executive team and backed by world‑class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune‑mediated diseases can live life fully.

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.

Qualifications

• Perform other duties and responsibilities as assigned
• 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

Benefits

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule
• Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.

Equal Employment Opportunity

Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Reasonable Accommodation

If you require a reasonable accommodation to participate in the application or interview process, please contact [e-mail] to request an accommodation. We are committed to providing equal access to all candidates.

Privacy

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines