Title: Biostatistician 
Location: Home-based in the U.S. or Canada (East Coast Preferred)
Duration: 12 Months (contract-to-hire)

Requirements:
· MS or PhD degree in Biostatistics or a related field and 8+ years’ relevant experience within the life-science industry.

Job Overview:
Serve as a strategic and operational counterpart to a customer’s Biostatistical Lead. This role is fully integrated into the customer’s clinical development framework. The individual is responsible for providing statistical leadership and ensuring alignment with the customer’s standards, timelines, and strategic objectives across assigned clinical programs.
 
Key Responsibilities
Strategic Engagement:

• Liaise with cross-functional teams to drive quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions.
• Serve as a resource for the customer’s biostatistical department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials.
• Participate as lead statistician on major projects, including contributing to clinical development plans, contributing to the customer’s internal decision-making, and responding to regulatory queries.
• Provide statistical leadership in submission activities, including the development and production of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) documents.
• Study-Level Statistical Leadership:
• Lead the development and refinement of Statistical Analysis Plans (SAPs) in close coordination with a customer’s biostatistics and clinical stakeholders.
• Provide statistical input into protocol design, amendments, and other key study documents.
• Ensure scientific rigor in statistical methodologies.
• Monitor and explore blinded data during study conduct to support strategic decision-making, identification of intercurrent events, and early smoke signal detection related to data collection quality, such as inconsistencies or missingness patterns.
• Mentor and guide the biostatistics and programming team at to help ensure alignment with the customer’s standards and expectations.

Programming and Analysis Coordination:

• Partner with the customer’s statistical programming team and other biostatisticians to plan and execute dry run activities, ensuring readiness for database lock and final analysis.
• Review and validate key statistical outputs including TLFs (Tables, Listings, Figures), and final study reports.
• Support interpretation of statistical results and contribute to data-driven decision-making.
• Support to Customer’s Strategic-level Statistician:
• Act as an extension of the customer’s biostatistics function, helping to prepare materials, conduct exploratory analyses, and troubleshoot data or methodological issues.
• Facilitate efficient communication and coordination between and the customer’s teams to maintain alignment and responsiveness.

Quality and Compliance:

• Ensure deliverables meet the customer’s quality standards and comply with regulatory guidelines (e.g., ICH-GCP, FDA, EMA).
• Maintain alignment with the customer’s processes, templates, and documentation standards.

Requirements:

• MS or PhD degree in Biostatistics or a related field and 8+ years’ relevant experience within the life-science industry.
• Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials.
• Expert in strategically collaborating with clinical and drug development experts.
• Experience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries.
• In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines.
• Strong working knowledge of SAS or R.
• Excellent knowledge of CDISC Data Standards.
• Superb communication and collaboration skills.
• Independent and proactive problem-solving skills.
• Rare disease and immunology experience is greatly preferred

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 55.00/hr.