• Author and lead the development of regulatory submission documents, including: Regulatory briefing books, eCTD modules and other complex regulatory documentation
• Develop document strategies, structure, and messaging aligned with regulatory objectives.
• Serve as a SME for regulatory writing across programs.
• Act as the program lead for assigned writing projects, coordinating cross-functional input.
• Translate complex scientific and clinical data into clear, compliant regulatory narratives.
• Collaborate with clinical, regulatory, biostatistics, and program leadership teams.
• Ensure documents meet regulatory agency expectations and submission standards.

• Extensive regulatory medical writing experience within pharma or biotech
• Proven experience authoring regulatory submission documents, including briefing books and eCTD modules
• Demonstrated ability to develop document strategies and lead authoring from concept to submission
• Strong experience handling highly complex regulatory documentation
• Excellent communication, leadership, and stakeholder management skills
• Ability to function as a program lead across cross-functional teams

• 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

• 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

• 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

• West Coast: ~6-hour overlap with China; flexibility for late afternoon/evening PST collaboration

• East Coast: ~6-hour overlap with EU; flexibility for early morning EST collaboration (approx. 5:00–11:00 AM EST)

Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
No 3rd party candidates

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.

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

The role is approximately 50% traditional biometrics programming and 50% AI-driven workflow development, making it ideal for candidates who combine strong SAS expertise with genuine curiosity and hands-on experience leveraging AI in clinical programming environments.

This is not a heads-down SAS-only role. They are looking for someone who communicates well, takes ownership, and can help scale AI initiatives across the organization.

Key Responsibilities

Clinical Programming (50%)

• Develop clinical datasets and generate Tables, Listings, and Figures (TLFs)
• Perform QC and validation of statistical outputs
• Support biometrics deliverables aligned with regulatory standards
• Partner closely with biostatistics and medical affairs (including publications support)
• Contribute to programming documentation and project timelines

AI Working Group Contributions (50%)

• Actively use ChatGPT (Enterprise preferred) to enhance programming efficiency
• Apply advanced prompting techniques to refine AI-generated outputs
• Support AI-driven workflows for:
  • QC automation
  • Table generation
  • Coding assistance (SAS/R/Python)
• Collaborate on proof-of-concept initiatives and internal AI tools
• Help evolve and scale AI adoption across biometrics

Required Qualifications

Technical

• Strong SAS programming experience within clinical trials
• Hands-on experience with dataset development and TLF production
• Solid understanding of regulatory/statistical outputs
• QC programming experience
• Exposure to biostatistics concepts and clinical data standards

AI / Innovation (Required – not optional)

• Practical experience using ChatGPT in a professional setting (Enterprise preferred)
• Strong prompting skills (ability to iterate and refine outputs)
• Demonstrated interest in AI workflow integration
• Python exposure is a plus
• Experience exploring AI agents is a strong plus

Soft Skills (Critical Success Factors)

Must demonstrate:

• Clear communication in group settings
• Proactive project ownership and follow-through
• Strong status reporting and stakeholder updates
• Accountability and independent workload management
• Confidence contributing in collaborative environments

Technical Environment

• SAS (primary)
• Some R for graphics (not a major focus)
• Increasing use of LLM-assisted SAS/R generation

Nice-to-Haves

• AI agent experience
• Real-world data exposure
• Strategic curiosity around AI applications
• Comfort operating in evolving workflows

Essential Functions

• Support the design, review, and execution of epidemiological research projects using administrative claims data/ EMR or other appropriate data sources, including development of protocols, contributing to statistical analysis plans (SAPs), reviewing and interpreting study results, and abstract and manuscript development.
• Stay current with research on epidemiological methodology and its applications as pertinent to project needs.
• Oversee and manage study team communication, project milestones, dissemination of results to key members, including internal and external collaborators.
• Work collaboratively with members of study teams to meet study and recurring report timelines.

Minimum Requirements

• PhD degree in epidemiology (or similar area) with 2+ years' research experience or MS in epidemiology (or similar area) with 4+ years research experience
• At least 2 years with analytic experience of healthcare claims databases/EMR
• Deep understanding of observational study design and analysis and ability to lead multi-disciplinary teams required to support program, project and contract management and financial reporting
• Experience designing and analyzing epidemiological studies, from protocol development through public dissemination (e.g. abstracts and manuscripts)
• Previous experience with safety studies (PASS)

Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
No 3rd party candidates

Biostatistician

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.

Key Responsibilities

• 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

Required 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

Preferred Qualifications

• 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)

This is a high-impact, on-call opportunity for a statistician who thrives in early-phase clinical research and wants to contribute strategic value without committing to a full-time role. While initially fractional, the position may evolve based on study load and team needs—making it ideal for experienced professionals looking to partner deeply without traditional constraints.

Position Summary:

The Scientific Manager of Biostatistics is responsible for supporting and advising clients on all aspects of PD data collection and analysis.

This role involves developing the PD analysis sections of the SAP and shells for tables, listings, and figures (TLFs), consulting with clients on PD analysis strategies, and ensuring data quality and accuracy through review and validation.

This position requires strong pharmacodynamic (PD) endpoint expertise, including extensive work with subjective measures, VAS pain scales, and biomarker-driven analyses.

Responsibilities:

• Develop the PD Analysis section of the Statistical Analysis Plan (SAP) and corresponding PD shells.
• Consult with clients on PD analysis strategies and subject allocation.
• Provide statistical design and methodology support for PD-related endpoints.
• Ability to apply solid judgment to select and implement appropriate statistical techniques based on study objectives, data characteristics, and regulatory expectations
• Review PD tables, figures, and listings (TFLs) to ensure quality and consistency.
• Collaborate cross-functionally with internal teams and clients.
• Participate in team meetings and strategic planning discussions.

Skills:

• Must be a clear, concise, and effective communicator—able to translate complex statistical concepts into actionable insights for clinical and cross-functional teams.
• Professional attitude and strong interpersonal skills.
• Ability to work well with a multi-disciplinary team of professionals.
• Client-focused approach to work.
• Solution-focus and ability to creatively solve problems and resolve issues.
• Ability to take initiative and use sound judgment.
• Ability to acquire and apply knowledge quickly.
• Flexible attitude and an ability to effectively prioritize.
• Deep understanding of clinical research, statistical principles, drug development process, and applicable regulatory guidelines as they relate to complex phase I studies of CNS-acting compounds.
• Significant Phase I clinical trial experience, including Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study designs, execution, and analysis.
• Strong technical aptitude and expertise in statistical analysis principles specific to PD data.
• Working knowledge of SAS programming.
• Good computer skills (Microsoft Word, Excel, and PowerPoint) and ability to understand and adapt to various information technology (IT) systems.

Experience with Specific Data Types:

• VAS (Visual Analog Scales)
• Pulmometry (Lung Function Testing)
• Psychedelic-related data and endpoints

Education and Experience:

• Master's degree in Statistics, Biostatistics, or a related field (Ph.D. preferred).
• Minimum of 5 years of relevant experience as a statistician, with a focus in pharmacodynamic data.
• Experience with CNS and early-phase studies preferred.
• Prior CRO experience is a plus.

Key Responsibilities

• Build and run clinical trial simulations to support study design decisions.
• Perform advanced data wrangling, cleaning, and transformation in R and PostgreSQL.
• Work across modern data platforms (Databricks, PostgreSQL, etc.) to integrate, query, and prepare datasets.
• Develop reproducible, well-documented R code for modeling, analysis, and reporting.
• Leverage Seql (Posit’s new AI-assisted R/Python tool) to accelerate analysis and automate code generation.
• Collaborate with biostatistics, data science, and engineering teams to optimize workflows and improve data accessibility.
• Support onboarding and integration of new team members into R-based and database environments.

Required Skills & Experience

• Fluency in R for programming, data manipulation, and simulation.
• Strong SQL experience (preferably PostgreSQL) for querying and data integration.
• Proven experience with clinical trial simulations, adaptive/study design, or statistical modeling.
• Expertise in data wrangling and structuring messy datasets for analysis.
• Comfort working in modern data ecosystems (e.g., Databricks, cloud data warehouses, pipelines).
• Excellent documentation and communication skills, with a collaborative, problem-solving mindset.

Nice to Have

• Familiarity with Seql (Posit’s AI-assisted R/Python tool).
• Experience in biostatistics, clinical research, or pharma/biotech environments.
• Exposure to Bayesian simulation, Monte Carlo modeling, or reproducible R workflows (e.g., R Markdown, Quarto).

Ideal Candidate Profile
This role is perfect for someone who sits between a data engineer and a biostatistician — an independent problem solver who can connect analytical goals with the technical backbone needed to achieve them. You’ll thrive if you’re comfortable in R, fluent in SQL, and excited to explore emerging tools that make working with data faster, smarter, and more intuitive.

$75-$100 hourly W2 / $85-$110 hourly 1099, commensurate with experience