Senior Biostatistician - Oncology Clinical Trials
New
E
EDETEKClinical Research
United States. Poland. Romania. Ukraine. India. BulgariaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5 to 8+ years
- Required Skills
- GCPR
Requirements
- Master’s degree or PhD in Statistics, Biostatistics, or a related quantitative field
- 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 is a plus
- Strong written and verbal communication skills
- Ability to manage multiple studies and priorities in a fast-paced CRO environment
- 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
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
- 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
- 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
- Work with cross-functional teams on tumor assessment data, adjudication, and endpoint derivation
- 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
- Work effectively within blinded and unblinded team structures and maintain strict confidentiality
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