Senior Biostatistician

📋 Description

• Develop statistical methodologies, protocols, and sample size calculations for both pre-market and post-market clinical studies.

• Strategize data collection methods and create or review case report forms to ensure alignment with the study design.

• Assess the reliability and validity of source information, apply weightings to raw data, and present results in a format compatible with software requirements.

• Design clinical trials, analyze study data to confirm device safety and efficacy, and produce Statistical Analysis Plans (SAPs).

• Conduct advanced statistical analyses utilizing appropriate methodologies.

• Interpret findings and deliver strategic insights.

• Review clinical literature and assess Real-World Evidence (RWE) to establish performance objectives.

• Draft reports summarizing trial outcome statistics, specifying data sources and limitations regarding reliability and usability, for in-house, regulatory, and publication target audiences.

• Prepare statistical reports for regulatory submissions (FDA, CE Mark, and other authorities such as TUV) and respond to regulatory inquiries.

• Conduct analyses and produce visual/tabular data for scientific presentations and publications.

• Collaborate with cross-functional team members (clinical affairs, data management, pre-clinical, and R&D engineers) to define endpoints, assess safety reporting, and prepare for submissions, ensuring data integrity and accurate analyses.

• Create statistical tables and data summaries as required.

• Review project database structures, edit checks, and data management coding conventions.

• Ensure adherence to industry standards and guidelines.

• May participate in relevant scientific and/or medical meetings.

• Assist in the publication of study findings.

⛳️ Requirements

• PhD in Biostatistics, Statistics, or a related field is required.

• Over 8 years of relevant experience in medical device or pharmaceutical clinical trials.

• Strong understanding of clinical trial design and statistical methodologies.

• Familiarity with regulatory guidelines, submissions, and documentation.

• Extensive knowledge of study designs and statistical analysis applications in one or more therapeutic areas.

• Must possess advanced data processing and/or computer programming skills.

• Advanced knowledge of statistical techniques, terminology, methodologies, and application software.

• Working knowledge of FDA data reporting requirements.

• Proficiency in statistical programming languages (e.g., SAS or Python).

• Demonstrated expertise in advanced and complex statistical methodologies, including experience with adaptive designs or Bayesian methods.

• Proficient in Microsoft Office Suite applications.

• Excellent oral and written communication skills, coupled with critical thinking abilities.

• Ability to work diligently and with minimal supervision, exercising good judgment, taking initiative to complete short and long-term projects, and recommending actions with little guidance.

• Capability to function as a team member, manage multiple tasks, and adapt flexibly to the evolving priorities and requirements of a dynamic, rapidly growing organization.

• Ability to lift 10-15 pounds.

🏝️ Benefits

• Comprehensive Benefits - A range of health insurance plans and supplemental insurance options, along with a 401k retirement savings plan.

• Ownership and Rewards - Stock option awards and an Employee Stock Purchase Plan (ESPP) to participate in our success.

• Work-Life Balance - Enjoy paid time off, paid holidays, a flexible work schedule, and a wellness program that includes an onsite gym and mindfulness classes.

• Diversity & Inclusion - A commitment to fostering a respectful work environment for our diverse workforce.