Senior Biostatistician

Leadership & Project Oversight

• Serve as the lead biostatistician on clinical study teams, accountable for statistical deliverables, quality, and timelines.
• Provide mentorship and oversight to statisticians and statistical programmers.
• Communicate project progress, risks, and resource needs to leadership.
• Ensure alignment of project execution with departmental and organizational goals.

• Lead the statistical design of clinical studies, including protocol development and statistical methodologies.
• Perform and review sample size and power calculations.
• Develop, review, and finalize statistical analysis plans (SAPs).
• Recommend innovative statistical approaches, endpoints, and reporting strategies aligned with study objectives.

• Provide statistical input into electronic data capture (EDC) design.
• Partner with data management to define edit checks and ensure high-quality data collection.
• Ensure study data supports interim and final analyses and regulatory requirements.

• Develop, validate, or oversee statistical programming using SAS and other tools (e.g., R, Python).
• Review outputs for accuracy, quality, and compliance with standards.
• Guide programming specifications, table shells, and reporting frameworks.

• Lead preparation and review of interim analyses, final study reports, and regulatory submissions.
• Contribute to manuscripts, abstracts, integrated summaries, and ad hoc analyses.
• Communicate complex statistical concepts and results to non-statistical stakeholders and senior leadership.

• Ensure compliance with GCP, FDA, ICH, and other applicable regulatory standards.
• Maintain audit-ready documentation and high-quality, submission-ready deliverables.
• Contribute to the development and refinement of statistical SOPs and best practices.

• Collaborate with clinical operations, data management, physicians, and external partners.
• Interface with regulatory agencies, data monitoring committees, and steering committees.
• Build strong client relationships and support business development initiatives.

• Provide statistical consulting across therapeutic and technical domains.
• Support specialized activities such as randomization design, unblinded statistician roles, and integrated summaries of safety and efficacy.
• Represent the organization through publications, conference participation, and professional engagement.

• PhD or Master’s degree in Biostatistics, Statistics, or related field with at least 5 years of experience in clinical trial data analysis
• Demonstrated programming proficiency in SAS (version 9.0 or higher)
• Experience supporting Phase I–III clinical trials
• Strong knowledge of ICH guidelines and regulatory requirements; familiarity with FDA submission processes
• Familiarity with CDISC standards (e.g., SDTM, ADaM) for regulatory submissions
• Proven leadership experience managing projects and mentoring team members
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint)
• Experience working on integrated summaries of safety and efficacy (ISS/ISE) or similar large-scale reporting efforts
• Strong analytical, organizational, and problem-solving skills with high attention to detail
• Excellent communication and interpersonal skills, with the ability to convey complex statistical concepts clearly
• Ability to manage multiple trials and priorities simultaneously with minimal disruption to productivity

• Experience with FDA/NDA submissions and regulatory interactions
• Experience working in a client-facing or CRO environment
• Therapeutic area expertise
• Proficiency in R, Python, or other advanced analytical tools
• Track record of contributions to publications, abstracts, or conference presentations

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
• Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
• 11 paid holidays
• 15 - 25 vacation days based on years of service
• Paid sick time…