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Job Description Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com 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.