Biostatistician (Contractor

About the job

BIOSTATISTICIAN (1yr CONTRACT)

NYHelus Pharma (NASDAQ: HELP) is a clinical stage biopharmaceutical company empowering the healing process by turning Novel Serotonergic Agonists () into Breakthroughs in Mental Health.

Founded in 2019, the company operates in Canada, the United States, the United Kingdom, the Netherlands, and Ireland. Helus Pharma is set to transform the mental health treatment landscape with key near-term milestones including its lead program HLP
003, which has been granted FDA Breakthrough Therapy Designation, in Phase 3 development for the adjunctive treatment of Major Depressive Disorder, and HLP
004 in development for generalized anxiety disorder.

Helus Pharma has a robust pipeline of proprietary NSAs with potential for expansion into additional mental health indications with high unmet need. The company's mission to help minds heal is supported by a strong intellectual property portfolio and a work force that is driven by compassion and the urgent need for better mental health solutions. The Helus Pharma team is working together to build a pathway to make accessible, scalable, and transformative care available to millions of people worldwide.

The Biostatistician (Contractor) provides statistical support for early-phase clinical development programs, with primary responsibility for assigned Phase 1 clinical studies. Reporting to the Director, Biostatistics, this role partners closely with Clinical Development, Clinical Pharmacology, Data Management, Medical Writing, and external Contract Research Organizations (CROs) to ensure the delivery of high-quality statistical analyses and study deliverables.

The position serves as the primary statistical representative for assigned studies, overseeing statistical activities performed by external vendors while ensuring analyses, datasets, and reporting meet protocol requirements, regulatory expectations, and internal quality standards. The role supports study planning, execution, database lock, statistical reporting, and clinical study documentation throughout the clinical trial lifecycle.

Working within a highly regulated biotechnology environment, the Biostatistician contributes to the integrity, consistency, and scientific quality of clinical data by reviewing statistical outputs, performing quality control activities, and providing technical expertise across cross-functional development teams.

This is an individual contributor role with no direct people management responsibilities.

• Serve as the lead biostatistician for assigned Phase 1 clinical studies, providing statistical support throughout study planning, conduct, analysis, and reporting.
• Act as the primary statistical liaison with external CRO biostatisticians and statistical programmers, managing day-to-day communications, deliverables, timelines, and issue resolution.
• Review and provide consolidated feedback on Statistical Analysis Plans (SAPs), analysis specifications, Tables, Figures and Listings (TFLs), analysis datasets, and statistical programming outputs prepared by external vendors.
• Perform quality control reviews of statistical deliverables produced by CROs to ensure accuracy, completeness, and compliance with protocol and regulatory requirements.
• Conduct quality control of internally generated statistical analyses supporting clinical pharmacology, translational research, scientific publications, abstracts, and presentations.
• Collaborate with Clinical Pharmacology to support pharmacokinetic (PK), pharmacodynamic (PD), exposure-response, and related statistical analyses.
• Partner with Data Management throughout study execution by reviewing Case Report Forms (CRFs), Data Transfer Agreements (DTAs), transfer specifications, edit checks, and database lock readiness activities.
• Provide statistical input during protocol development, including endpoint selection, sample size considerations, randomization methodologies, and statistical methodology.
• Review Interactive Response Technology (IRT) specifications and randomization documentation to ensure alignment with study protocols and statistical requirements.
• Support blinded data review activities by identifying data quality concerns and collaborating with cross-functional teams to resolve issues prior to database lock.
• Review clinical study reports to ensure statistical analyses and interpretation accurately reflect study results.
• Ensure statistical deliverables comply with CDISC standards, including SDTM and ADaM requirements where applicable.
• Apply ICH guidelines, Good Clinical Practice (GCP), and applicable FDA and EMA regulatory guidance in the execution of statistical activities.
• Contribute to the development, review, and continuous improvement of departmental Standard Operating Procedures (SOPs), statistical templates, quality control checklists, and best practices.
• Identify opportunities to improve statistical processes, CRO oversight, document consistency, and operational efficiency…