Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
No 3rd party candidates
The Biostatistician applies statistical expertise across clinical research projects, independently supporting or leading studies, performing statistical analyses, and delivering high-quality statistical documents and outputs in support of sponsors' clinical development programs.
The ideal candidate has strong applied biostatistics experience and proficiency in SAS and R, including tables, figures, and listings (TFLs), inferential analyses, and randomization. This individual will collaborate with Statistical Programming, Data Management, Clinical, and other cross-functional teams while independently contributing to statistical deliverables and quality review.
Experience supporting Phase 1 and early clinical development studies is strongly preferred, including familiarity with early-phase study designs, safety and tolerability endpoints, pharmacokinetic/pharmacodynamic (PK/PD) data, dose escalation, and exploratory analyses.
Responsibilities
- Follow company SOPs, templates, processes, and policies.
- Serve as the study Biostatistician for assigned clinical trials and statistical point of contact for internal teams and clients, as appropriate.
- Provide statistical input into study design, protocols, project timelines, and clinical development activities.
- Review clinical study protocols and provide statistical recommendations.
- Develop randomization schedules using SAS, R, or other validated software, as applicable.
- Develop, perform, and QC statistical analyses for clinical studies.
- Develop or contribute to Statistical Analysis Plans (SAPs), including TFL specifications and shells.
- Develop and review summary statistics, inferential analyses, TFLs, and graphical displays.
- Support analyses of safety, tolerability, PK/PD, and other clinical endpoints, as applicable.
- Use SAS, R, and other statistical tools to perform or validate analyses and results.
- Review programming outputs for accuracy and consistency with protocols and SAPs.
- Perform QC review of statistical analyses, specifications, outputs, and documents.
- Collaborate with Statistical Programming, Data Management, Clinical, Medical, and other teams to ensure timely, accurate delivery of study outputs.
- Represent Biostatistics in client, study team, and cross-functional meetings.
- Support regulatory submissions and responses to regulatory questions as needed.
- Conduct work in accordance with SOPs, GCP, and applicable regulatory guidelines.
- Maintain knowledge of applicable regulatory requirements and guidance, including FDA, EMA, ICH, and GCP.
- Participate in process and quality improvement initiatives as appropriate.
- Perform other duties as assigned.
Education
- Master's degree in Statistics, Biostatistics, or a related quantitative field required.
Core Competencies
- Excellent written and verbal communication skills.
- Ability to communicate effectively with cross-functional teams regarding timelines, deliverables, statistical considerations, and issues.
- Strong interpersonal skills and a collaborative, client-focused approach.
- Ability to work independently and effectively within a team.
- Strong organizational and prioritization skills with high attention to detail.
- Flexibility in managing changing priorities and study requirements.
- Understanding of the clinical research lifecycle and applicable regulations.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
Statistical & Technical Skills
- Ability to support or own statistical deliverables from study design through analysis and reporting.
- Proficiency in SAS and R, including statistical programming, data analysis, and inferential statistical methods.
- Experience developing and reviewing SAPs and TFL specifications and shells.
- Ability to review statistical programming outputs for accuracy and alignment with study specifications and SAPs.
- Experience reviewing clinical study protocols.
- Familiarity with aCRFs, eCRFs, and clinical data structures.
- Working knowledge of CDISC standards, including SDTM and ADaM.
- Ability to review SDTM and ADaM datasets and specifications from a statistical perspective.
- Experience with Phase 1 or early-phase clinical trials preferred.
- Familiarity with early-phase analyses, including safety, tolerability, PK/PD, dose escalation, and exploratory endpoints, preferred.
