Director Biostatistics

Hartmann Young; Boston (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Hartmann Young, a clinical-stage oncology biotechnology partner, is seeking a Director of Biostatistics to provide statistical leadership across its development portfolio. The role involves hands-on leadership from early-phase through registrational development, partnering with Clinical Development, Regulatory Affairs, and Data Management.

The successful candidate will oversee study designs, robust statistical analyses, and regulatory interactions with authorities such as FDA/EMA, while

Qualifications

• PhD or Master's in Biostatistics or related quantitative discipline.
• Typically 8-12+ years of clinical biostatistics experience in biotech/pharma; Master’s may require more.
• Experience leading oncology clinical development and regulatory interactions.

Responsibilities

• Lead biostatistics for oncology programs from protocol development to regulatory submission.
• Design Phase I-III trials with endpoints, sample size, interim analyses, and adaptations.
• Prepare and review SAPs, DHPs, and CSRs; ensure CDISC compliant deliverables.
• Manage CROs/vendors, timelines, budgets and quality of deliverables.
• Mentor junior biostatisticians and coordinate with cross-functional teams.

Skills

SAS

R

Leadership

Communication

CRO management

Education

PhD or Master’s in Biostatistics

8-12+ years in biotech/pharma

Tools

CDISC (SDTM/ADaM)

Clinical trial design

Job description

Hartmann Young is exclusively partnered with an innovative, clinical-stage oncology biotechnology company developing next-generation therapeutics for patients with difficult-to-treat cancers. The company is entering an exciting period of clinical and organisational growth and is now looking to appoint a Director of Biostatistics to provide statistical leadership across its expanding development portfolio.

Position Summary

The Director of Biostatistics will provide hands-on statistical leadership across oncology clinical-development programs, from early-phase studies through registrational development. Working closely with Clinical Development, Clinical Operations, Regulatory Affairs, Data Management and Programming, this individual will ensure that study designs and statistical analyses are scientifically rigorous, operationally practical and aligned with global regulatory requirements.

The Director will serve as the statistical lead for assigned programs, oversee external partners and contribute to the continued development of internal biostatistics capabilities, standards and processes.

Responsibilities

• Serve as the lead biostatistician for assigned oncology programs and provide statistical leadership from protocol development through study reporting and regulatory submission.
• Lead the statistical design of Phase I-III clinical trials, including endpoint selection, sample-size calculations, randomisation, interim analyses and adaptive-design considerations.
• Develop and review statistical sections of clinical protocols, statistical analysis plans, data-review plans and clinical study reports.
• Partner with Clinical Development to define development strategies, evaluate clinical evidence and support data-driven program decisions.
• Lead the interpretation and communication of clinical data to internal teams, senior leadership, investigators and external stakeholders.
• Support regulatory submissions, including INDs, NDAs, BLAs and responses to statistical questions from health authorities.
• Contribute to meetings and interactions with the FDA, EMA, NMPA, PMDA and other global regulatory authorities.
• Ensure statistical deliverables comply with applicable regulatory guidance, ICH standards and CDISC requirements, including SDTM and ADaM.
• Oversee the development and quality review of tables, listings and figures in partnership with Statistical Programming and Data Management.
• Manage CROs and statistical vendors, including scope development, vendor selection, timelines, budgets, performance and quality of deliverables.
• Identify study-level risks and proactively resolve statistical, data-quality and execution issues.
• Contribute to the development and implementation of biostatistics standards, templates, SOPs and governance processes.
• Apply innovative statistical methodologies and analytical approaches where they can strengthen decision-making or improve trial efficiency.
• Collaborate with Clinical Operations, Medical Affairs, Pharmacovigilance, Regulatory Affairs, Quality and Translational Medicine to ensure statistical alignment across programs.
• Provide guidance and mentorship to junior biostatisticians and programmers and, as the function grows, potentially manage internal team members.
• Support publications, conference presentations, investigator materials and other scientific communications.

Education and Experience

• PhD or Master's degree in Biostatistics, Statistics or a related quantitative discipline.
• Typically 8-12+ years of clinical biostatistics experience within the biotechnology or pharmaceutical industry; candidates with a Master's degree may require additional relevant experience.
• Significant experience supporting oncology clinical development, including early- and late-stage trials.
• Experience serving as the statistical lead for clinical studies or development programs.
• Strong knowledge of clinical-trial design, statistical methodology and the interpretation of oncology endpoints.
• Experience contributing to global regulatory submissions and interactions with health authorities such as the FDA, EMA, NMPA or PMDA.
• Experience supporting NDA or BLA submissions and registrational trials is strongly preferred.
• Working knowledge of CDISC standards, including SDTM and ADaM, and experience overseeing submission-ready statistical deliverables.
• Proficiency with SAS and familiarity with R or other statistical programming environments.
• Demonstrated experience overseeing CROs, vendors or outsourced statistical activities.
• Strong understanding of ICH guidelines, GCP and global clinical-development requirements.
• Previous people-management or mentoring experience is desirable but not essential.
• Excellent communication and presentation skills, with the ability to explain complex statistical concepts to non-statistical stakeholders.
• Proven ability to manage multiple priorities and operate effectively within a fast-paced, cross-functional environment.

What We Offer

• The opportunity to provide meaningful statistical leadership across innovative oncology development programs.
• A collaborative environment in which you can influence clinical strategy and work closely with experienced scientific and development leaders.
• Competitive compensation, including base salary, performance bonus and equity.
• A comprehensive employer-paid benefits package.
• Flexible paid time off and two one-week company-wide shutdowns each year.
• Access to professional-development resources, mentorship and opportunities to expand your leadership responsibilities as the organisation grows.