Senior Biostatistician
EDETEK, Inc., Poland, ME, United States
The Senior Biostatistician provides statistical support and leadership for oncology clinical trials across multiple phases of development. This role works closely with sponsors and cross‑functional teams to support study design, protocol development, statistical analysis planning, data interpretation, and study reporting. The Senior Biostatistician is expected to contribute strong technical expertise, effective client communication, and high‑quality delivery of statistical work products in a CRO environment.
Candidates with CRO experience are strongly preferred. Experience supporting oncology studies and Data Monitoring Committee (DMC/IDMC) activities is also preferred.
Essential Functions and Responsibilities
Provide statistical support for clinical trials from study start‑up through final reporting and regulatory submission.
Contribute statistical input to study design, sample size determination, endpoint definition, randomization, and analysis strategy.
Author or review statistical sections of protocols, statistical analysis plans, mock shells, and other study documents.
Collaborate with sponsors, clinical teams, data managers, statistical programmers, medical writers, and regulatory teams throughout the study lifecycle.
Review statistical analyses and outputs, including tables, listings, and figures, to ensure quality, accuracy, and consistency.
Support interim analyses, safety reviews, efficacy analyses, and final study reporting.
Participate in the review of ADaM specifications, derived endpoints, and analysis datasets.
Support the preparation of DMC materials, including review of analysis outputs and summaries for DMC meetings, in accordance with applicable procedures and confidentiality requirements.
Interpret statistical results and communicate findings clearly to internal teams and sponsors.
Ensure study deliverables are completed on time and in compliance with SOPs, regulatory requirements, and sponsor expectations.
Support responses to sponsor questions, audit requests, and health authority queries related to statistical matters.
Provide guidance to junior statisticians and support departmental process improvement and standardization efforts.
Contribute to proposal development, bid defenses, and budget assumptions as needed.
Oncology‑Specific Responsibilities
Support oncology studies involving endpoints such as ORR, DOR, PFS, OS, BOR, CBR, and TTR.
Contribute to statistical strategies for time‑to‑event analyses, censoring rules, subgroup analyses, and sensitivity analyses.
Support studies using RECIST, iRECIST, or other disease‑specific response criteria, as applicable.
Work with cross‑functional teams on tumor assessment data, adjudication, and endpoint derivation.
DM/CIDMC Experience
Support statistical activities related to DMC/IDMC reviews for ongoing clinical trials.
Assist with preparation and review of DMC analysis outputs, safety summaries, and meeting materials.
Contribute to DMC charter review and statistical content, where applicable.
Work effectively within blinded and unblinded team structures and maintain strict confidentiality.
Qualifications
Master’s degree or PhD in Statistics, Biostatistics, or a related quantitative field.
Typically 5 to 8+ years of relevant biostatistics experience in clinical research, pharmaceutical, biotechnology, or CRO settings.
CRO experience strongly preferred.
Experience supporting oncology clinical trials preferred.
Experience supporting DMC/IDMC activities preferred.
Strong knowledge of statistical methodology used in clinical trials, including survival analysis, categorical data analysis, and longitudinal data analysis.
Good understanding of ICH, GCP, and applicable regulatory requirements.
Experience developing or reviewing SAPs, protocols, and statistical outputs.
Familiarity with CDISC standards, including SDTM and ADaM.
Proficiency in SAS required. Familiarity with R a plus.
Strong written and verbal communication skills.
Ability to manage multiple studies and priorities in a fast‑paced CRO environment.
Preferred Qualifications
PhD preferred but not required.
Experience supporting global clinical trials and regulatory submissions.
Experience in early‑phase or late‑phase oncology studies.
Experience interacting directly with sponsors in a client‑facing role.
Mentoring or training experience is a plus.
Working Relationships
The Senior Biostatistician works closely with:
Sponsors and external clients
Biostatistics and statistical programming teams
Data management teams
Clinical operations and medical teams
Medical writing and regulatory teams
DMC‑related teams, where applicable
Success Measures
Timely and high‑quality delivery of statistical outputs
Strong support for study design, analysis, and reporting
Positive sponsor and team feedback
Compliance with timelines, SOPs, and regulatory expectations
Effective collaboration across functions
Benefits
Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.
Choice of comprehensive Medical, Vision and Dental Insurance plans
Paid vacation time and sick days
Corporate holidays annually
Participation in the 401K Plan
Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.
Health Advocate and Employee Assistance Program
Location
This is a remote position, and we are open to candidates based in the United States, India, Ukraine, Bulgaria, Poland, and Romania.
Equal Opportunity Employer Statement
EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.
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Candidates with CRO experience are strongly preferred. Experience supporting oncology studies and Data Monitoring Committee (DMC/IDMC) activities is also preferred.
Essential Functions and Responsibilities
Provide statistical support for clinical trials from study start‑up through final reporting and regulatory submission.
Contribute statistical input to study design, sample size determination, endpoint definition, randomization, and analysis strategy.
Author or review statistical sections of protocols, statistical analysis plans, mock shells, and other study documents.
Collaborate with sponsors, clinical teams, data managers, statistical programmers, medical writers, and regulatory teams throughout the study lifecycle.
Review statistical analyses and outputs, including tables, listings, and figures, to ensure quality, accuracy, and consistency.
Support interim analyses, safety reviews, efficacy analyses, and final study reporting.
Participate in the review of ADaM specifications, derived endpoints, and analysis datasets.
Support the preparation of DMC materials, including review of analysis outputs and summaries for DMC meetings, in accordance with applicable procedures and confidentiality requirements.
Interpret statistical results and communicate findings clearly to internal teams and sponsors.
Ensure study deliverables are completed on time and in compliance with SOPs, regulatory requirements, and sponsor expectations.
Support responses to sponsor questions, audit requests, and health authority queries related to statistical matters.
Provide guidance to junior statisticians and support departmental process improvement and standardization efforts.
Contribute to proposal development, bid defenses, and budget assumptions as needed.
Oncology‑Specific Responsibilities
Support oncology studies involving endpoints such as ORR, DOR, PFS, OS, BOR, CBR, and TTR.
Contribute to statistical strategies for time‑to‑event analyses, censoring rules, subgroup analyses, and sensitivity analyses.
Support studies using RECIST, iRECIST, or other disease‑specific response criteria, as applicable.
Work with cross‑functional teams on tumor assessment data, adjudication, and endpoint derivation.
DM/CIDMC Experience
Support statistical activities related to DMC/IDMC reviews for ongoing clinical trials.
Assist with preparation and review of DMC analysis outputs, safety summaries, and meeting materials.
Contribute to DMC charter review and statistical content, where applicable.
Work effectively within blinded and unblinded team structures and maintain strict confidentiality.
Qualifications
Master’s degree or PhD in Statistics, Biostatistics, or a related quantitative field.
Typically 5 to 8+ years of relevant biostatistics experience in clinical research, pharmaceutical, biotechnology, or CRO settings.
CRO experience strongly preferred.
Experience supporting oncology clinical trials preferred.
Experience supporting DMC/IDMC activities preferred.
Strong knowledge of statistical methodology used in clinical trials, including survival analysis, categorical data analysis, and longitudinal data analysis.
Good understanding of ICH, GCP, and applicable regulatory requirements.
Experience developing or reviewing SAPs, protocols, and statistical outputs.
Familiarity with CDISC standards, including SDTM and ADaM.
Proficiency in SAS required. Familiarity with R a plus.
Strong written and verbal communication skills.
Ability to manage multiple studies and priorities in a fast‑paced CRO environment.
Preferred Qualifications
PhD preferred but not required.
Experience supporting global clinical trials and regulatory submissions.
Experience in early‑phase or late‑phase oncology studies.
Experience interacting directly with sponsors in a client‑facing role.
Mentoring or training experience is a plus.
Working Relationships
The Senior Biostatistician works closely with:
Sponsors and external clients
Biostatistics and statistical programming teams
Data management teams
Clinical operations and medical teams
Medical writing and regulatory teams
DMC‑related teams, where applicable
Success Measures
Timely and high‑quality delivery of statistical outputs
Strong support for study design, analysis, and reporting
Positive sponsor and team feedback
Compliance with timelines, SOPs, and regulatory expectations
Effective collaboration across functions
Benefits
Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.
Choice of comprehensive Medical, Vision and Dental Insurance plans
Paid vacation time and sick days
Corporate holidays annually
Participation in the 401K Plan
Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.
Health Advocate and Employee Assistance Program
Location
This is a remote position, and we are open to candidates based in the United States, India, Ukraine, Bulgaria, Poland, and Romania.
Equal Opportunity Employer Statement
EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.
#J-18808-Ljbffr