Biostatistics Lead, Clinical Development

Beeline Medicines Corporation; Boston (MA); Hybrid; USD 181.000 - 235.000; Vollzeit

Benefits dieser Stelle

Health and wellness coverage

Paid time off

Zusammenfassung

Beeline Medicines is seeking an Associate Director, Biostatistics to lead statistical strategy for clinical development, design studies, plan analyses, and oversee deliverables from CROs. You will partner with cross‑functional teams and ensure outputs meet ICH and regulatory expectations.

The role requires a PhD in Biostatistics and at least five years in pharma/biotech stats, with strong SAS or R skills, Bayesian/frequentist methods, and experience with adaptive trials.

Qualifikationen

• PhD in Biostatistics, Statistics, or a closely related quantitative discipline required.
• 5 years of biostatistics experience in pharma/biotech/CRO settings preferred.
• Experience in immunology or related therapeutic areas preferred.
• Advanced proficiency in SAS and/or R for analysis and programming.
• Strong knowledge of clinical trial design, ICH E9, and CDISC ADaM.
• Experience with adaptive trial designs and interim analyses.
• Experience with CRO statistical oversight and governance.

Aufgaben

• Serve as lead statistician for one or more clinical studies from protocol to CSR.
• Develop SAPs, sample size/power calculations, and randomization schemes.
• Oversee tables, listings, and figures (TLFs) with CROs or in-house.
• Collaborate on study design, protocol development, and data review.
• Contribute statistical input to regulatory submissions and briefing documents.
• Review clinical study reports and publications for statistical accuracy.
• Ensure compliance with ICH guidelines and regulatory standards.
• Perform other duties as assigned.

Kenntnisse

Statistical leadership

SAS

R

Trial design

ICH E9

CRO oversight

Cross-functional comms

Bayesian methods

Ausbildung

PhD in Biostatistics

Tools

SAS

R

Jobbeschreibung

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 asTuesday 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

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

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.

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

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