Associate Director – Biostatistics

Replimune

Associate Director guiding biostatistics for Replimune’s oncolytic cancer immunotherapy trials. Designing analyses, supporting regulatory submissions, and leading statistical work across clinical studies.

Posted 8/4/2026full-timeWoburn • Massachusetts • 🇺🇸 United StatesSenior💰 $193,500 - $250,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Biostatistics and Statistical Analysis, with a strong focus on clinical trial support, regulatory submissions, and advanced study design methodologies. Proficient in SAS programming and capable of leading biostatistical efforts for oncology studies.

Highest-signal resume keywords

PhD Or MS In Biostatistics Or StatisticsSAS ProgrammingClinical Trial ExperienceNDA/BLA Regulatory SubmissionsAdvanced Study Design

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Statistical Analysis PlansBiostatisticsEfficacy AnalysesData MonitoringSDTM/ADaM KnowledgeClinical Study ReportsProcess ImprovementsStatistical MethodologiesIndependent Statistician ExperienceDatabase Lock Activities

Soft Skills

Interpersonal SkillsLeadership SkillsCommunication SkillsCollaborative WorkIndependent Work

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryOncologySolid TumorECTDPre-IND ActivitiesNDA/BLA ActivitiesBiometrics Team ManagementCRO Project ActivitiesRegulatory Submissions

About the role

Key responsibilities & impact

Provide statistical support to the compound statistical leader for clinical development plans and clinical trials
Provide statistical input to study protocols
Develop statistical analysis plans, tables, listings, and figures
Support database monitoring and lock activities
Serve as biostatistics lead for assigned clinical studies, publications, and conference presentations
Assist with clinical study reports and publications
Monitor and guide internal biometrics team and CRO project activities, including timelines, deliverables, and resources
Participate in pre-IND and NDA/BLA activities
Use SAS for efficacy analyses and validation of important data derivations when necessary
Develop and implement department standards and lead process improvements
Perform other duties as assigned

Requirements

What you’ll need

PhD or MS in Biostatistics or Statistics required
At least 3 years’ experience for PhD, or 5 years’ experience for MS, as a statistician in the pharmaceutical or biotechnology industry
Oncology, especially solid tumor, clinical trial experience preferred
Knowledge of advanced study design and up-to-date biostatistical methodologies
Experience with NDA/BLA eCTDs or other global regulatory submissions preferred
Experience as an independent statistician with responsibility for multiple studies or projects
Excellent interpersonal, leadership, and communication skills
Ability to work independently and collaboratively
Good knowledge of statistical programming languages, including SAS
Knowledge of SDTM/ADaM
Remote candidates living beyond 65 miles of Woburn HQ must be open to 15–25% travel to Woburn HQ every 4–6 weeks or as business needs require
Lawful authorization to work in the country for the role is requested in the application

Benefits

Comp & perks

Annual performance incentive bonus
New hire equity
Ongoing performance-based equity
Medical insurance
Dental insurance
Vision insurance
401(k) match
Flexible time off
Paid holidays, including year-end shutdown
Remote work option
Competitive and forward-looking total rewards program