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.
Requirements
- 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 is 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.
Job Types: Full-time, Contract
Pay: $70.00 - $80.00 per hour
Work Location: Remote
