Job Details

Statistical Consultant

Location: Remote

Job Type: Full-Time

Salary: $120,000 – $140,000 per year

Required Technical Skills:

• Strong proficiency in SAS and/or R programming.
• Hands-on experience creating and validating ADaM datasets.
• Expertise in generating Tables, Listings, and Figures (TLFs).
• Solid understanding of CDISC standards, including SDTM and ADaM.
• Experience implementing Statistical Analysis Plans (SAPs).
• Knowledge of clinical trial design, statistical methodologies, and regulatory requirements.
• Experience supporting therapeutic areas such as Oncology, Immunology, Neuroscience, or other clinical research domains.
• Excellent analytical, troubleshooting, and problem-solving skills.
• Strong communication and collaboration abilities within cross-functional clinical teams.

Key Responsibilities:

• Statistical Programming:
• Develop and validate ADaM datasets based on approved specifications.
• Implement Statistical Analysis Plans (SAPs) and programming specifications.
• Perform statistical programming using SAS/R while adhering to company standards and SOPs.
• Support statistical analyses required for clinical studies and regulatory submissions.
• Reporting & Deliverables:
• Produce high-quality Tables, Listings, and Figures (TLFs) for Clinical Study Reports (CSRs), safety analyses, publications, and regulatory submissions.
• Ensure programming outputs are accurate, traceable, and compliant with regulatory expectations.
• Perform ad hoc analyses to support study teams and business needs.
• Documentation & Quality:
• Prepare programming specifications, validation documentation, and programming deliverables.
• Conduct quality control reviews and resolve programming issues.
• Maintain documentation in accordance with internal and regulatory requirements.
• Collaboration:
• Work closely with biostatisticians, clinical operations, data management, and regulatory teams.
• Provide programming support throughout the clinical trial lifecycle.
• Participate in submission activities, audits, inspections, and regulatory responses.
• Process Improvement:
• Develop reusable macros and automation tools to improve programming efficiency.
• Contribute to process improvements and implementation of best practices.
• Mentor junior programmers and provide technical guidance when needed.

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.