Senior Oncology Biostatistics Director, Remote

Scientific Search; Boston (MA); Remote; USD 250,000 - 300,000; Full time

Job summary

Scientific Search in Remote position seeks a Senior or Executive Director of Biostatistics to lead statistical strategy across solid tumor programs, guide study design, analysis, and publication activities, and oversee outsourced biostatistics work ensuring timely, high-quality deliverables.

You will collaborate with medical directors, trial management, data management, and other teams, contribute to regulatory submissions and publications, and help shape the statistical leadership within the

Qualifications

• Master's degree in Statistics or Biostatistics.
• 5+ years of directly relevant biostatistics experience.
• Experience supporting BLA/NDA filings with health authorities.
• Strong R programming skills required; SAS experience preferred.
• Oncology therapeutic area experience.
• Knowledge of CDISC standards and validation.
• Experience with Medidata RAVE and clinical data structures.
• Ability to design trials and develop SAPs.

Responsibilities

• Collaborate with the clinical development team in designing clinical trials ensuring that statistical principles are applied appropriately.
• Support the clinical development team in global Health Authority interactions as the Biostatistics representative.
• Responsible for randomization plans, where applicable.
• Collaborate with data management and clinical operations to align statistical analysis plans with data collection procedures and forms.
• Facilitate and participate in cross functional review of outsourced statistical deliverables such as statistical analysis plans, TLF shells and specifications, SDTM/ADaM datasets, etc.
• Provide scientifically rigorous statistical input and review of clinical protocols, interpretation of statistical results and scientific publications.
• Work with stakeholders to define business questions, requirements, timelines, objectives, and success criteria to address needs. Participate in regularly scheduled meetings that require statistical input.
• Develop strategies to address health authorities’ inquiries pertaining to biostatistics.
• Provide programming support across development to support delivery of summarized tabular/graphic analyses for inclusion in publications and external scientific meetings and multi-dimensional nonclinical and clinical data analyses.
• Maintain and modify in-house code.

Skills

R programming

SAS

Oncology

BLA/NDA experience

CDISC knowledge

GxP/ICH FDA knowledge

Data analysis planning

Education

Master's degree in Statistics/Biostatistics

Tools

Medidata RAVE

CDISC standards

Job description

Scientific Search in Remote position seeks a Senior or Executive Director of Biostatistics to lead statistical strategy across solid tumor programs, guide study design, analysis, and publication activities, and oversee outsourced biostatistics work ensuring timely, high-quality deliverables.

You will collaborate with medical directors, trial management, data management, and other teams, contribute to regulatory submissions and publications, and help shape the statistical leadership within the