Penfield Search Partners

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Senior Biostatistician 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. - Follow department and company standard operating procedures (SOPs), forms, templates, and policies. - 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). - Participate in or lead quality improvement initiatives. - Other duties as assigned. Qualifications - 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.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We are seeking a highly experienced Statistical Programmer to lead programming activities across global clinical studies. This role operates beyond executional programming, with responsibility for oversight of CRO deliverables, validation of outputs, and end-to-end accountability for statistical programming packages. - Lead statistical programming activities across global studies (EU and China exposure preferred) - Serve as primary programming lead in collaboration with Biostatistics - Develop, review, and validate SDTM and ADaM datasets in accordance with CDISC standards - Review specifications and proactively challenge inconsistencies in protocols, SAPs, and dataset definitions - Validate program outputs and ensure accuracy, quality, and regulatory compliance - Provide oversight and guidance to CRO partners, consolidating and communicating feedback effectively - Manage timelines, delivery packages, and milestone commitments - Contribute to continuous improvement of programming processes and standards Qualifications - Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or related field - 5+ years of SAS programming experience within pharmaceutical/biotech - Strong understanding of statistical methods used in clinical trial analysis - Knowledge of Good Programming Practices and GCP - Preferred: Experience with R programming Requirements - Strong expertise in CDISC standards, including ADaM and SDTM - Demonstrated experience reviewing specs and ensuring high-quality, submission-ready deliverables - Experience validating CRO programming deliverables - Ability to operate with increased performance accountability and ownership - Strong CRO-facing communication and collaboration skills - Proven ability to manage multiple global studies simultaneously Time Zone Requirements - West Coast: ~6-hour overlap with China; flexibility for late afternoon/evening PST collaboration - OR - East Coast: ~6-hour overlap with EU; flexibility for early morning EST collaboration (approx. 5:00–11:00 AM EST)

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We are seeking an experienced Contract Biostatistician to provide part-time statistical consulting support for a growing medical device company. This role will focus on the design, analysis, and interpretation of clinical studies involving human subjects, with an emphasis on diagnostic device performance and sensitivity testing. The ideal candidate has prior experience working with medical device clinical data and can operate independently in a fast-paced, resource-lean environment. - Provide statistical expertise for medical device studies involving human patients, including study design, analysis planning, and interpretation of results - Support diagnostic device studies, including evaluation of sensitivity, specificity, and other performance characteristics - Conduct and review sensitivity analyses to assess robustness of study results - Develop or review statistical analysis plans (SAPs) for device clinical studies - Analyze clinical and diagnostic data and summarize results for internal teams and external stakeholders - Collaborate with clinical, regulatory, and engineering teams to support regulatory submissions and study reporting - Provide ad hoc statistical consultation as needed Qualifications - Prior experience supporting medical device clinical studies involving human subjects - Hands-on experience with diagnostic studies, including sensitivity analyses - Strong knowledge of statistical methods relevant to medical device evaluation - Ability to work independently as a consultant and communicate findings clearly to non-statistical stakeholders Requirements - Master’s degree in Statistics, Biostatistics, or a related field - Experience supporting studies intended for regulatory submission (e.g., FDA, notified bodies) - Familiarity with common statistical software (e.g., SAS, R, or equivalent)