About This Role:

About This Role:
We are seeking a detail-oriented and technically skilled Biostatistician/Data Analyst III to support the design, analysis, documentation, and reporting of clinical and healthcare-related activities. This position provides ongoing statistical and SAS programming support for Quality, production-related analyses, FDA and other regulatory topics, clinical studies, and scientific communications, with a focus on cardiology medical devices. The role requires strong statistical expertise and advanced proficiency in SAS programming to ensure the integrity, accuracy, and traceability of analyses used by cross-functional teams and in regulatory submissions.

Essential Duties and Responsibilities:

- Design and analyze clinical trials and observational studies in collaboration with cross-functional teams.
- Develop and validate SAS programs for data manipulation, statistical analysis, and report generation.
- Create and review statistical analysis plans (SAPs), study protocols, and data specifications.
- Perform quality control checks on datasets, tables, listings, and figures (TLFs), including materials supporting Quality and regulatory activities.
- Conduct statistical analyses using SAS and interpret results in the context of study objectives, quality questions, production needs, and FDA topics.
- Provide statistical consultation and programming support to Clinical Research, Quality, Production, and other cross-functional teams.
- Support FDA remediation, regulatory submissions, responses to agency questions, and associated documentation in compliance with applicable standards (e.g., CDISC, FDA, ICH).
- Present statistical findings and explain analytical methods to internal and external stakeholders in a clear and concise manner.
- Maintain and apply current statistical methodologies, SAS programming techniques, and best practices for data quality and reproducibility.

Experience and Minimum Qualifications:

- Master's or PhD in Biostatistics, Statistics, or a related field.

-At least 3 years of biostatistics or statistics work experience.
- Strong proficiency in SAS programming (Base, Macro, SQL, and Statistical procedures).
- Experience with clinical trial data and regulatory submissions (e.g., CDISC SDTM/ADaM standards).
- Knowledge of statistical methods such as regression, survival analysis, and mixed models.
- Familiarity with other statistical software (e.g., R, STATA) is a plus.
- Excellent problem-solving, communication, and teamwork skills.
- Ability to manage multiple projects and meet tight deadlines with high attention to detail.

Location:
Remote - US

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range
$99,000.00 - $129,000.00