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.
DMC / IDMC 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.