Biostatistician Phase 1 Statistical Support - Remote

Penfield Search Partners Ltd.; Fairfield (CT); Remote; USD 120,000 - 180,000; Full time

Job summary

Penfield Search Partners Ltd. seeks a Biostatistician to provide Phase 1 statistical support, lead studies, and deliver high-quality analysis documents for sponsors' programs.

The ideal candidate has strong SAS skills (including TFLs, inferential analyses, and randomization) and can collaborate with the programming team while contributing to SAPs, TFLs, and QC. Experience with first-in-human and dose-escalation studies is highly desirable.

Qualifications

• Phase 1 clinical trial experience is highly desirable.
• Strong SAS programming, including TFLs and SAPs.
• Ability to develop SAPs and TFL shells.
• Regulatory knowledge of FDA/EMA/GCP.

Responsibilities

• Follow SOPs, templates, and policies.
• Develop and QC statistical analyses for trials.
• Develop SAPs and TFL shells.
• Coordinate with internal teams and clients.
• Review protocols and randomization schedules.
• Represent Biostatistics in client and inter-department meetings.

Skills

SAS programming

TFLs

Inferential analyses

Randomization

CDISC SDTM

ADaM specs

Pinnacle 21

Cross-functional collaboration

Education

Master's Degree in Statistics

Tools

Pinnacle 21

Job description

Contact: Terra Parsons - [e-mail] 3rd party candidatesJob Summary:The Biostatistician Phase 1 Statistical Support 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 ResponsibilitiesFollow 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 CompetenciesExcellent verbal and written communicationAbility to communicate proactively and clearly with cross-functional teams to ensure alignment on study timelines, deliverables and issues.Professional attitude and strong interpersonal skillsCollaborative, client-focused mindsetFlexible with work assignments and learningStrong organizational and prioritization skillsHigh attention to detailUnderstanding of clinical research life cycle and regulationsProficient in Microsoft Word, Excel, PowerPointStatistical & Technical SkillsOwn statistical deliverables from design through analysis (e.g., SAPs, TFLs)Moderate SAS programming proficiency, including the ability to perform inferential statistical analysesReview programming output for accuracy and alignment with SAPProtocol reviewReview of aCRF / eCRFCreating and reviewing SAPsCreating and writing TFL specs and shellsUnderstanding of CDISC standards (SDTM, ADaM)SDTM specifications and domain reviewADaM specification writing and domain reviewADRG (Analysis Data Reviewer’s Guide) creation and reviewPinnacle 21 review and input