Biostatistician

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

The Opportunity That Awaits You:

The Biostatistician plays a critical role in the design, analysis, and interpretation of clinical trials and studies that support the development, regulatory approval, and post-market surveillance. This position requires a strong background in biostatistics, a deep understanding of clinical research methodologies, and the ability to work collaboratively in a cross-functional team environment. This role reports into the Senior Director of Clinical Affairs.

What Your Day-To-Day Will Involve:

• Study Design and Protocol Development: Collaborate with clinical and regulatory teams to design robust clinical trials and observational studies, ensuring statistical rigor and compliance with regulatory requirements. Develop statistical analysis plans (SAPs) and contribute to the development of study protocols, including sample size calculations and randomization strategies.




• Data Analysis and Interpretation: Perform statistical analyses of clinical trial data, including descriptive statistics, hypothesis testing, survival analysis, and regression models. Interpret and present the results of statistical analyses to internal teams, regulatory agencies, and external stakeholders.




• Regulatory Support: Provide statistical input and support for regulatory submissions, including preparation of statistical sections for premarket approval (PMA), 510(k) submissions, and technical documentation for CE marking. Participate in meetings with regulatory agencies to address statistical questions and provide expert testimony as needed.




• Data Management and Quality Assurance: Collaborate with the data management teams to ensure the accuracy, consistency, and completeness of clinical data. Implement and monitor quality control procedures for statistical analyses, ensuring compliance with Good Clinical Practice (GCP) guidelines.




• Cross-Functional Collaboration: Work closely with clinical, regulatory, R&D, and quality teams to align statistical methodologies with the overall development strategy of the company’s medical devices. Provide statistical training and guidance to non-statisticians within the organization.




• Scientific Communication: Prepare statistical reports, manuscripts, and presentations for publication in peer-reviewed journals and conferences. Communicate complex statistical concepts to diverse audiences, including clinicians, engineers, and regulatory professionals.

The Qualifications We Need You to Possess

• Minimum of 3-5 years of experience in biostatistics within the medical device, pharmaceutical, or biotechnology industries.
• Proven experience in the design and analysis of clinical trials, including clinical reports and peer reviewed publications, with a strong understanding of regulatory requirements for medical devices (e.g., FDA, EMA).
• Proficiency in statistical software such as SAS, R, or equivalent.
• Experience with data management practices and tools (e.g., CDISC, SDTM, ADaM) is preferred. 
• Relevant certifications (e.g., PStat®, GStat) are a plus

The Qualifications We Would Like You to Possess

• Master’s or PhD in Biostatistics, Statistics, or a related field is preferred.

For US-Based Candidates Only

Work Authorization Status: Citizen / Permanent Resident

For this role, the anticipated base pay range is $133,000-$ 190,000 per year.

Plus, eligibility for an annual bonus and equity/RSUs.

Understanding PROCEPT's Culture

At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.

And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.

An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!

BENEFITS OF WORKING AT PROCEPT! 

PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.

PAY RANGE TRANSPARENCY

Procept is committed to fair and equitable compensation practices. The pay range(s) for this role is listed below and represents base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.

WORK ENVIRONMENT

We’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.