Principal Biostatistician

Edwards Lifesciences; Oakland (CA); Remote; USD 129,000 - 182,000; Full time

Job summary

Join a forward-thinking company dedicated to transforming patient care through innovative technologies. As part of the Clinical Affairs team, you will leverage your expertise in biostatistics to drive evidence for clinical trials, ensuring optimal patient outcomes. This role involves collaboration with medical professionals and regulatory authorities, making a significant impact on the development of groundbreaking therapies. If you are passionate about improving patient lives and thrive in a dynamic environment, this opportunity offers the chance for professional growth and advancement.

Benefits

Competitive salaries

Performance-based incentives

Wide variety of benefits programs

Qualifications

• Ph.D. or Master's in Biostatistics/Statistics with experience in clinical trials.
• Strong expertise in statistical methodologies and clinical trial design.

Responsibilities

• Lead statistical analyses for clinical trials and regulatory submissions.
• Collaborate with stakeholders for statistical expertise in product development.

Skills

Statistical methodologies

Clinical trial design

Data analysis

SAS

R

Communication skills

Leadership skills

Problem-solving skills

Education

Ph.D. in Biostatistics or Statistics

Master's Degree in Biostatistics or Statistics

Tools

PASS

EAST

Job description

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

You will make an impact by...

• Representing the TMTT Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind.
• Act as statistical lead on one or more clinical trials, lead the coordination of analyses for study reports and other documents, and provide programming and validation support of these analyses.
• Statistical lead on Protocol and SAP development as well as CSRs.
• Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD/IDE) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed.
• Collaborate with statistical programming team on TLF shells development, data analysis and validation of TLFs.
• Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update.
• Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team.
• Compile technical documents for internal and external audits.
• Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs).
• Collaborate on developing case report forms and clinical database to ensure quality data collection.
• Lead the efforts of data analysis for data monitoring committee as needed.

What you'll need (Required):

• Ph.D. in Biostatistics, Statistics, or related; plus, 2 full years of previous biostatistics, analytical experience in clinical trials.
• Master's Degree in Biostatistics, Statistics, or related; plus, 5 full years of previous biostatistics, analytical experience in clinical trials.

What else we look for (Preferred):

• Medical Device experience.
• Capable of independently leading pivotal trials.
• Experience in trial simulations for sample size and power calculation.
• Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses.
• Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting.
• Proven expertise in SAS and R.
• Exposure to using PASS or EAST.
• DMC/DSMB exposure.
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills.
• Keeps abreast of new developments in statistics and regulatory guidance.
• Excellent problem-solving, organizational, analytical and critical thinking skills.
• Strong leadership skills and ability to influence change.
• Ability to provide training and coaching to lower level employees.
• Experience in facilitating change, including collaboration with management and executive stakeholders.
• Strict attention to detail.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

The base pay range for this position is $129,000 to $182,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).

#LI-Remote

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.