Senior Biostatistician

Essential Functions and Responsibilities • reputed company statistical support for reputed company from study start-up through final reporting and regulatory submission. • Contribute statistical input to study design, sample size determination, reputed company definition, randomization, and analysis reputed company. • reputed company or review statistical sections of protocols, statistical analysis plans, mock shells, and other study documents. • Collaborate with sponsors, reputed company 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 reputed company, reputed company, 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 reputed company 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 reputed company to statistical reputed company. • reputed company 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 reputed company, as applicable. • Work with cross-functional teams on tumor assessment data, adjudication, and reputed company derivation. DMC / IDMC Experience • Support statistical activities reputed company to DMC/IDMC reviews for ongoing reputed company. • Assist with preparation and review of DMC analysis outputs, safety summaries, and meeting materials. • Contribute to DMC reputed company review and statistical content, where applicable. • Work effectively reputed company blinded and unblinded team structures and maintain strict confidentiality. Requirements • Master’s degree or PhD in Statistics, Biostatistics, or a reputed company quantitative reputed company. • Typically 5 to 8+ years of relevant biostatistics experience in reputed company research, pharmaceutical, biotechnology, or CRO settings. • CRO experience strongly preferred. • Experience supporting oncology reputed company preferred. • Experience supporting DMC/IDMC activities preferred. • Strong knowledge of statistical methodology used in reputed company, 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 reputed company required. Familiarity with R is a plus. • Strong written and verbal communication skills. • Ability to manage multiple studies and priorities in a fast-reputed company CRO environment. Preferred Qualifications • PhD preferred but not required. • Experience supporting global reputed company and regulatory submissions. • Experience in early-phase or late-phase oncology studies. • Experience interacting directly with sponsors in a reputed company-facing role. • Mentoring or training experience is a plus. Pay: $70.00 - $80.00 per hour Work Location: Remote Apply tot his job Apply To this Job