Job Description
JOB DESCRIPTION Job Description Contact: Neisha Camacho/Terra Parsons - 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 Apply tot his job