Biostatistician, Clinical Affairs

Job Description

Leading the team and providing expert statistical support for internally sponsored, real‑world evidence (RWE), and external clinical studies. Requires a deep understanding of statistical methodologies, sample size calculations, and regulatory requirements within the medical device industry. Requires strong leadership skills, the ability to navigate complex analyses, and proficiency in statistical software. Collaborate closely with cross‑functional teams to ensure the successful development and approval of medical devices.

Demonstrate strong communication and presentation skills and support senior leaders in data analytics.

• Lead and manage the biostatistics team, providing guidance and mentorship to junior biostatisticians.
• Develop and implement statistical methodologies for sample size calculations and power analysis.
• Generation of randomization schedules.
• Order, collate and interpret large volumes of diverse data and perform exploratory and confirmatory statistical analysis for studies.
• Manage various datasets, determine summary statistics, conduct hypothesis testing, estimate statistical models, report formats and other analysis considerations.
• Design and conduct complex statistical analyses for clinical studies, RWE, and other data needs.
• Prepare statistical analysis plans including development of well‑presented mock‑up displays for tables, listings, and figures.
• Review and provide input to study protocols and clinical study reports.
• Collaborate with cross‑functional teams, including Regulatory Affairs, R&D, ADO, and Marketing, to ensure robust statistical support for product validation and claims.
• Ensure compliance with regulatory requirements and industry standards for statistical practices.
• Present findings and statistical insights to stakeholders, including senior management and regulatory bodies, and effectively communicate statistical concepts.
• Stay updated with the latest advancements in biostatistics and medical device regulations.
• Deliver special projects / ad‑hoc reporting as needed.

Lance Soft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.

Lance Soft makes hiring decisions based solely on qualifications, merit, and business needs at the time.