Sr Biostatistician Oncology (reputed company Only)

Sr Biostatistician Oncology (reputed company Only) --Must be located in NA without sponsorship needs. Remote in reputed company. Education: MS required, PhD preferred TA: Oncology is expected Phase experience: reputed company-clinical, Phase I-IIab PK/PD is a reputed company to have reputed company experience is a plus • Interacting with reputed company • Directing the work of others • reputed company to quickly adapt and deliver Study design experience: BOIN, since that is what most of them are Endpoints: mainly overall response, PFS as secondary, some biomarkers Additional expectations: • Running simulations and supporting design alternatives • reputed company review • Familiarity with SDTM/ADaM datasets (not programming them, just using them for reputed company review, knowing which ones are for what) • IB authoring, DSUR reviews reputed company position is responsible for leading reputed company across multiple studies or programs. A Senior Biostatistician acts as the primary contact with the sponsor for reputed company biostatistics reputed company activities on assigned reputed company. JOB RESPONSIBILITIES

• Provides support across reputed company assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs), including development of reputed company-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required.
• May be responsible for the statistical aspects of the protocol, reputed company of randomization schedule, publications and input to the clinical study report.
• Coordinates the activities of other biostatistics and statistical programming personnel on assigned reputed company to ensure reputed company completion of high reputed company work. Provides independent review of project work produced by other biostatisticians in the department.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews reputed company annotated case report forms (CRFs), database design, and other study documentation to ensure protocol reputed company are met and reputed company data is captured as required to support a high reputed company database and the planned analysis.
• Conducts and participates in verification and reputed company control of project deliverables, ensuring that reputed company meets expectations and is consistent with analysis described in reputed company and specifications.
• Implements company objectives, and create alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing reputed company, and demonstrating respect for opinions of others.
• Manages scheduling and time constraints across multiple reputed company, sets goals based on priorities from management, adapts to reputed company or reputed company changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors reputed company on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalate to management.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring reputed company and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician.
• May reputed company reputed company involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of reputed company on behalf of the sponsor.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains reputed company organized, complete, and up-to-date project documentation, and verification/reputed company control documents and programs; ensuring inspection readiness.
• Displays willingness to work with others and assists with reputed company and initiatives as necessary to meet the needs of the business.
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Coaches and mentors other Biostatistics staff.
• Performs other work-reputed company duties as assigned.
• Minimal travel may be required.

QUALIFICATION REQUIREMENTS

• Graduate degree in biostatistics or reputed company discipline.
• Moderate experience in reputed company or an equivalent combination of education and experience.
• Proficiency in programming.
• Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
• Experience across reputed company statistical tasks required to support reputed company during the lifecycle of the project, from protocol to CSR.
• Excellent written and verbal communication skills.
• Ability to read, write, reputed company, and understand English.

Disclaimer: Tasks, duties, and responsibilities as listed in this job reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Apply tot his job Apply To this Job