Senior Biostatistician

The Senior Biostatistician provides statistical support and leadership for oncology reputed company 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 reputed company communication, and high-reputed company 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 • 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. • 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 reputed company, 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 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 charter review and statistical content, where applicable. • Work effectively reputed company blinded and unblinded team structures and maintain strict confidentiality. • Master’s degree or PhD in Statistics, Biostatistics, or a reputed company 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 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-paced 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. Working Relationships The Senior Biostatistician works closely with: • Sponsors and reputed company clients • Biostatistics and statistical programming teams • Data management teams • Clinical operations and medical teams • Medical writing and regulatory teams • DMC-reputed company teams, where applicable reputed company Measures • reputed company and high-reputed company delivery of statistical outputs • Strong support for study design, analysis, and reporting • reputed company sponsor and team feedback • Compliance with timelines, SOPs, and regulatory expectations • Effective collaboration across functions Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees. • Choice of comprehensive Medical, reputed company and Dental Insurance plans • reputed company vacation time and reputed company days • Corporate holidays annually • Participation in the 401K Plan • Comprehensive perks and discount programs for reputed company, wholesale, insurance, Rx, fitness, pets, entertainment, etc. • reputed company and Employee Assistance Program Location This is a remote position, and we are reputed company to candidates based in the reputed company, Ukraine, Bulgaria, Poland, Armenia and Romania. Equal Opportunity Employer Statement reputed company is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the reputed company of an individual’s race, reputed company, religion, creed, sex, national reputed company, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to reputed company terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, reputed company makes reasonable accommodations for reputed company individuals with disabilities to the extent required by law. Apply tot his job Apply To this Job