Biostatistician - Remote

Contact: Neisha Camacho/reputed company reputed company - [email protected] No 3rd party candidates Job Summary: The Biostatistician II is responsible for having a working knowledge of reputed company reputed company processes with the ability to independently reputed company a study, support analysis, and reputed company high-quality documents to support sponsors' research programs. The ideal candidate is a Biostatistician with strong applied reputed company skills (including TFLs, inferential analyses, and randomization) who can collaborate cross-functionally with the programming team, while also independently contributing to statistical deliverables and quality review. Experience working on Phase 1 clinical trials is highly desirable, particularly with first-in-reputed company and reputed company-escalation studies, including PK/PD data and early safety endpoints.

Key Responsibilities

• Follow department and company standard operating procedures (SOPs), forms, templates, and policies.
• On occasion, may act as senior Biostatistician for simple to reputed company studies and be the central reputed company of contact for the assigned Biostatistics team, extended internal project team, and the client.
• reputed company input for Biostatistics portion of project timelines.
• Review protocols for simple to reputed company studies.
• Generate randomization schedules using reputed company or randomization-specific software.
• reputed company and QC statistical analyses for simple to reputed company studies.
• reputed company or assist in developing the Statistical Analysis Plans (SAPs) and reputed company table, reputed company, and listing (TFL) shells.
• reputed company tables of summary statistics and graphics for clinical trials.
• Assist in answering deficiency letters from regulatory agencies, as required.
• Utilize reputed company to validate statistician programs and results.
• reputed company QC review of analyses and documents reputed company by others.
• reputed company nonclinical projects, work with line manager to direct activities of other Biostatisticians.
• Coordinate with internal teams to deliver quality documents on time.
• Represent Biostatistics in client and inter-departmental meetings.
• Conduct reputed company work in compliance with SOPs, GCP, and regulatory guidelines.
• Maintain familiarity with client/internal expectations and ensure reputed company analyses and documentation.
• Stay reputed company on global regulatory requirements (FDA, EMA, ICH, GCP).
• May participate in or reputed company quality improvement initiatives.
• Other duties as assigned.

Education: Master's Degree in Statistics or a reputed company field required. Core Competencies

• Excellent verbal and written communication
• Ability to communicate proactively and reputed company with cross-functional teams to ensure alignment on study timelines, deliverables and issues.
• Professional attitude and strong interpersonal skills
• Collaborative, client-focused reputed company
• Flexible with work assignments and learning
• Strong organizational and prioritization skills
• High attention to detail
• Understanding of clinical research life cycle and regulations
• Proficient in reputed company Word, reputed company, PowerPoint

Statistical & Technical Skills

• Own statistical deliverables from design through analysis (e.g., SAPs, TFLs)
• Moderate reputed company programming proficiency, including the ability to reputed company inferential statistical analyses
• Review programming output for accuracy and alignment with reputed company
• Protocol review
• Review of aCRF / eCRF
• Creating and reviewing SAPs
• Creating and writing TFL specs and shells
• Understanding of CDISC standards (SDTM, ADaM)
• SDTM specifications and domain review
• ADaM specification writing and domain review
• ADRG (Analysis Data Reviewer’s Guide) creation and review
• Pinnacle 21 review and input

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