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Principal Biostatistician Consultant – Oncology

Consultant

• Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
• Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
• Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
• Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
• Responsible for validity of analysis and explore alternative analysis strategies as needed.
• Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
• Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
• Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
• Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians.
• Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Senior Statistician Consultant – Late Phase Hematology Oncology

Software Engineer

• The Senior Study Data Tabulation Model (SDTM) Statistical Programmer, provides oversight and creation of the SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine clinical development projects.
• Accountability predominantly includes creation and validation of study data standard deliverables (SDTM dataset, Define.XML, SDRG, aCRF), collaborating with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards.
• The incumbent will be responsible for continuous improvement of our electronic submission process for study data standards deliverables and providing tools and templates to assist delivery focusing on traceability, quality assurance, data conformance and data fitness.
• The position is a key collaborator with statistical programming, statistics, global data management, and other project stakeholders.

Senior SDTM Programmer/Analyst

• Provide statistical leadership across one or more clinical programs
• Lead the development and review of statistical deliverables, including protocols and regulatory submission materials
• Serve as a key statistical representative in cross-functional team discussions
• Ensure statistical approaches comply with regulatory standards and industry best practices
• Review and interpret analysis outputs for accuracy and regulatory compliance
• Collaborate with cross-functional teams
• Communicate statistical concepts clearly to stakeholders

Associate Director – Biostatistician

QA Engineer

• Provide independent GCP quality oversight for ongoing Phase IIb/III clinical trials.
• Review study documentation for compliance with: ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), Internal SOPs and quality standards.
• Assess protocol deviations, quality trends, and study-level risk indicators.
• Conduct remote GCP audits, including: CRO/vendor audits, TMF quality reviews, Process audits.
• Support FDA inspection readiness activities, including: Gap assessments, Mock inspection preparation, CAPA review and effectiveness checks.
• Track and trend audit findings.
• Evaluate CRO quality systems and oversight documentation.
• Review vendor audit reports and ensure appropriate follow-up.
• Provide quality input into vendor governance processes.
• Partner with Clinical Operations and functional leads to identify emerging quality risks, assess mitigation strategies, and ensure documentation supports inspection readiness.
• Support development and refinement of quality metrics and KPIs.
• Prepare clear, concise audit reports, develop executive summaries and quality trend reports, and maintain quality documentation tracking tools.

Clinical Quality Assurance Consultant

• Lead programming activities for oncology clinical trials across multiple studies.
• Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.
• Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.
• Provide SAS programming expertise to support complex data derivations and analyses.
• Review and ensure traceability, consistency, and quality of all programming deliverables.
• Act as programming lead for assigned studies, managing timelines and deliverables.
• Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs.
• Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards.
• Support integrated analyses including ISS/ISE.
• Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.
• Ensure all programming meets regulatory requirements (FDA, EMA, PMDA).
• Contribute to responses for regulatory queries and data requests.

Principal Statistical Programmer – Analyst Consultant

Clinical Operations

• Manages the delivery of study requirements to the protocol and regulations such as GCP and ISO 14155, the site needs and the required timelines set for the project.
• Apply principles, concepts and techniques for effective and proactive project management of a clinical study.
• Balances resource constraints (i.e. time, money, people, and equipment) against deliverables.
• Develop clinical study budget and may assist in quarterly departmental budget reviews.
• Seeks input from higher-level clinical experts or program management as issues warrant.
• Leverage experience and work with collaborative team members to recommend and implement methods for improving processes and addressing issues within the clinical operations department.
• Implement and maintain risk-based monitoring processes to drive efficient and effective study management.
• Oversee and review data and/or monitoring reports for protocol violations and serious protocol deviations, and proactively address violations/deviations, to assure protocol and GCP compliance.
• Train and mentor more junior staff on monitoring, internal procedures, and query resolution to assure alignment and GCP compliance.

Clinical Project Manager II

Senior/Principal Statistician Consultant – Late Phase Hematology Oncology

Principal Statistician Consultant – Late Phase Hematology

Director

• Lead statistical strategy for hematology studies across phases of development.
• Provide input into protocol design, study endpoints, estimands, and analysis methods.
• Author and review statistical sections of protocols, SAPs, and other key documents.
• Ensure alignment with regulatory expectations and industry standards.
• Oversee generation and validation of TLFs and other statistical outputs.
• Guide programming teams on analysis requirements and quality expectations.
• Interpret study results and provide statistical insights to cross-functional teams.
• Contribute to IND, NDA/BLA, and other global submissions.
• Participate in regulatory interactions, health authority questions, and responses.
• Work closely with Clinical Development, Medical, Data Management, and Programming.
• Provide mentorship and technical guidance to statisticians and programmers.
• Ensure adherence to SOPs, CDISC standards, and regulatory guidance.
• Promote efficient, reproducible, and high-quality statistical practices.

Associate Director, Statistics – Consulting – Hematology

Data Scientist

• Lead Data management activities and ensure study deliverables meet timelines and quality standards.
• Review of Clinical research documents (e.g. protocols, Case Report Forms).
• Create and review electronic Case Report Form (eCRF) specifications.
• Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan.
• Develop edit rules/checks, query logic and query messages.
• Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
• Create and provide training to the clinical team and sites.
• Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.
• Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis, and final database lock.
• Coordinate the archiving of study databases and related documents
• Create Data Transfer Specifications and perform external vendor reconciliation.
• Perform SAE reconciliation.
• Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.