Contact: Terra Parsons -
teamnt@penfieldsearch.com
No 3rd party candidates
Job 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 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 Reviewers Guide) creation and review
- Pinnacle 21 review and input