Contact: Neisha Camacho/Terra Parsons - [email protected] No 3rd party candidates Job Summary: The Biostatistician II is responsible for having a working knowledge of all related processes with the ability to independently lead a study, support analysis, and provide high-quality documents to support sponsors' research programs. The ideal candidate is a Biostatistician with strong applied SAS 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-human and dose-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 complex studies and be the central point of contact for the assigned Biostatistics team, extended internal project team, and the client.
• Provide input for Biostatistics portion of project timelines.
• Review protocols for simple to complex studies.
• Generate randomization schedules using SAS or randomization-specific software.
• Develop and QC statistical analyses for simple to complex studies.
• Develop or assist in developing the Statistical Analysis Plans (SAPs) and related table, figure, and listing (TFL) shells.
• Develop tables of summary statistics and graphics for clinical trials.
• Assist in answering deficiency letters from regulatory agencies, as required.
• Utilize SAS to validate statistician programs and results.
• Perform QC review of analyses and documents prepared by others.
• Oversee 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 all work in compliance with SOPs, GCP, and regulatory guidelines.
• Maintain familiarity with client/internal expectations and ensure aligned analyses and documentation.
• Stay current on global regulatory requirements (FDA, EMA, ICH, GCP).
• May participate in or lead quality improvement initiatives.
• Other duties as assigned.

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

• Excellent verbal and written communication
• Ability to communicate proactively and clearly with cross-functional teams to ensure alignment on study timelines, deliverables and issues.
• Professional attitude and strong interpersonal skills
• Collaborative, client-focused mindset
• 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 Microsoft Word, Excel, PowerPoint

Statistical & Technical Skills

• Own statistical deliverables from design through analysis (e.g., SAPs, TFLs)
• Moderate SAS programming proficiency, including the ability to perform inferential statistical analyses
• Review programming output for accuracy and alignment with SAP
• 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