Biostatistician

The Biostatistician will lead study design and biostatistical strategies, providing critical input into protocols, statistical analysis plans, and reports. As the primary statistical support for all of LumaBridge’s clinical trials, this role collaborates with clinical and project teams to ensure robust study designs and statistical solutions. Biostatisticians critique and enhance study designs across the organization while mentoring less experienced colleagues. Excellent communication skills and a collaborative mindset are essential.

Reports To: Director/VP of Biometrics or designee

Title(s): Biostatistician, Senior Biostatistician, Principal Biostatistician

Location: This is a home-based position.

Responsibilities:

• Collaborate with development and clinical investigators to design clinical trials, ensuring appropriate statistical methods and sample size for statistical justification of clinical outcomes.
• Draft statistical analysis plans capturing design elements and statistical methodology.
• Perform statistical activities supporting development and medical affairs studies, including protocol development, data analysis, and report preparation.
• Provide strategic input and contribute significantly to the design of clinical studies and development of statistical analysis plans.
• Specify statistical analyses and review statistical report results for accuracy.
• Work closely with statistical programmers to design clinical deliverables (including patient profiles) and validate programming code for tables, listings, and figures.
• Oversee and review statistical analyses conducted by programmers and other biostatisticians to ensure accuracy quality.
• Conduct and manage randomization and blinding processes.
• Troubleshoot and enhance existing statistical designs.
• Mentor less experienced colleagues and maintain expertise in state-of-the-art statistical analyses.
• Develop Biostatistics Standard Operating Procedures (SOPs).
• Collaborate with programmers to develop an internal library of codes/programs for common analysis data sets.
• Engage with clients as needed (ie protocol development and review, bid defenses, other consultation)
• Perform other duties as assigned.

Senior Biostatistician:

• Mentor junior or entry-level biostatisticians.
• Assist in the development and/or review of study plans, forms, and tools, and site training materials.
• Increasing client engagement.

Principal Biostatistician:

• Stay abreast of industry monitoring standards and implement across LumaBridge.
• May have line management responsibilities and oversight of team utilization and productivity.

Qualifications:

• M.S. in Biostatistics.
• Minimum 5 years of biostatistics experience associated with oncology clinical trials in CRO or pharmaceutical settings.
• Strong collaboration skills and ability to interact across departments.
• High attention to detail and proficiency in producing organized reports.
• Proficiency in statistical code writing and documentation.
• Knowledge of FDA guidelines for in vivo therapeutics and diagnostic devices, with a particular focus on the field of oncology, and the required statistical basis for sample size estimation, sensitivity, specificity, agreement rates, and reproducibility testing required for validation and FDA clearance and approval.
• Ability to work in a remote team environment.
• Knowledge of CDISC Data Standards: SEND, SDTM, ADaM.
• Proficient in SAS programming; knowledge of R preferred.

Senior Biostatistician:

5+ years of biostatistics experience associated with oncology clinical trials; 1+ year experience with LumaBridge preferred.

Expert in development of letters and reports or documents with limited revision/oversight required.

Principal Biostatistician:

8+ years of biostatistics experience associated with oncology clinical trials; 2+ years experience with LumaBridge preferred.

Subject Matter Expert (SME) (Individual contributor).

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.