Lead Statistical Programmer

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.

The Lead Statistical Programmer at Recor Medical is a key role responsible for driving statistical programming activities. This position involves developing and implementing statistical programming strategies, ensuring compliance with regulatory requirements, and fostering collaboration with cross-functional teams. Key responsibilities include leading programming activities, providing technical expertise, contributing to process improvement initiatives, and ensuring the accuracy, integrity, and timeliness of statistical programming deliverables. The Lead Statistical Programmer also plays a crucial role in staying updated with advancements in open-source statistical programming methodologies and technologies. Overall, this position requires strong leadership, technical proficiency, and a dedication to maintaining the highest standards of quality and compliance in statistical programming.

Responsibilities and Duties

• Oversee external statistical programming vendors services, including communication, guidance, monitoring, and issue resolution.
• Serve as the subject matter expert for the Data Visualization Team, guiding the creation of clinical programming listings, metric reports, and departmental dashboards.
• Develop and implement statistical programming strategies to support the design, analysis, and reporting of clinical studies and regulatory submissions.
• Collaborate with cross-functional teams including biostatisticians, project management, clinical data managers, scientific affairs, medical affairs, and regulatory affairs to ensure timely and accurate delivery of statistical programming deliverables.
• Review and contribute to study protocols, statistical analysis plans, CRF design, eCRF annotations and data specifications to provide input to Clinical Project and Data Management Team for analysis needs.
• Provide technical expertise in statistical programming methodologies and ensure adherence to industry standards and regulatory requirements (e.g., FDA, ICH guidelines).
• Oversee the development, validation, and maintenance of statistical analysis datasets and programming codes for clinical trials.
• Review and QC statistical outputs, tables, listings, and figures generated by the statistical programming team to ensure accuracy and consistency.
• Act as a subject matter expert in statistical programming for regulatory interactions and contribute to the preparation of regulatory submissions (e.g., IDEs, PMAs).
• Stay abreast of advancements in statistical programming methodologies and technologies and assess their potential application within the organization.
• Participate in process improvement initiatives to enhance efficiency, quality, and compliance within the statistical programming function.
• Other duties as assigned.

Requirements

• A minimum of a master’s degree in statistics, biostatistics, computer science, mathematics, or a related field.
• At least 5 years of experience managing statistical programming within the medical device or pharmaceutical industry.
• Previous experience in leading or managing a team of statistical programmers is highly desirable.
• Strong proficiency in statistical programming languages such as SAS and R.
• Experience with open-source statistical programming languages such as R is highly desirable.
• Familiarity with open-source statistical software packages and tools commonly used in clinical research.
• Experience with open-source submission platforms and formats, such as RMarkdown for regulatory submissions, is advantageous.
• Familiarity with regulatory requirements and guidelines (e.g., FDA, ICH) for clinical trials and submissions.
• Experience in developing and implementing statistical programming strategies for clinical studies.
• Knowledge of Clinical Data Interchange Standards Consortium (CDISC) compliance, Study Data Tabulation Model (SDTM) and the Analysis Data Models (ADaM) for regulatory submissions is desirable.
• Prior involvement in regulatory submissions (e.g., IDEs, PMAs) using open-source tools and platforms is advantageous.

$150,637 - $174,182 a year

Commensurate with experience, skills, education and training.

COVID-19 vaccination requirements

At Recor Medical, we care, we collaborate, we challenge, and we create. Pursuant to these core values, we are focused on the health and safety of our employees, as well as the teamwork essential for innovation of our pioneering technology. COVID-19 vaccines will be required for all ReCor US office employees effective June 10, 2021, as well as all new US office employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine.

Equal Employment Opportunity

At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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