Director, Biostatistics Operations

Director, Biostatistics Operations (Scientific Insights & Analytics) - Surgical Structural Heart

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

This is a unique opportunity for an experienced biostatistician/ stat programmer people leader to join the Scientific Insights & Analytics group (Biometrics & Scientific Communications) in the Surgical Structural Heart Valve business unit to support various global medical and clinical activities. This is a fast-paced, dynamic team working on innovative medical devices. The individual in this position will have opportunities in finding innovative approaches to generating evidence from various clinical trial data and real world data (RWD).

The Director of Biostatistics Operations is responsible for direct management of Biostatistics Operations team, including statistical methods and programming, on all aspects of the clinical development process; represents the team from biostatistics perspective on activities ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results; advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind; provide subject matter expertise in evidence generation and dissemination working with external key operating leaders including health care providers from academia.

You will make an impact by

• Holding accountable for clinical trials assigned to direct reports

• Providing technical/statistical leadership and strategic input to multiple and/or complex clinical projects/programs in collaboration with cross-functional teams

• Planning and manage complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables.

• Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams

• Developing and lead in the implementation of broad and more complex biostatistics strategies which may include negotiations with internal and external parties

• Holding accountable for clinical trials assigned to direct reports

• Keeping abreast of new developments in statistics, device development, and regulatory guidance

• Creating, maintaining, and implement improvements, standardizations, and globalizations of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) to ensure compliance, accuracy, efficiency, and optimization

• Providing guidance on process improvement projects within biostatistics and cross-functional areas

• Managing and oversee the work of Biostatistics Operations team, including statistical methods and programming

• Developing a robust talent development plan in alignment with functional growth strategies of the department.

• Providing resource analysis and planning for biostatistics functions

• Compiling technical documents for internal and external audits

• Generating internal report for management above

• Leading briefings and technical meetings for internal and external representatives

What you'll need (Required)

• Masters in Statistics or Biostatistics Plus 8+ years of previous related experience in analytical experience with clinical trials /clinical research

• Must be proficient with SAS

• Must have sound knowledge of theoretical and applied statistics

• Must have at least 2 years of people management experience

• Must be available to work on-site at our main campus in Irvine, California. Edwards will provide a comprehensive relocation package for a top candidate who is located 50 miles or greater from our campus location.

What else we look for (Preferred):

• Experience working in the medical device industry strongly preferred

Key Knowledge:

• Expert understanding of clinical trial design, including Bayesian and adaptive designs, while identifying applications of functional knowledge and methodologies to resolve complex problems

• Expert understanding of related aspects of biostatistics processes and/or systems

• Demonstrated ability to manage one or more teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations

Key Technical Experience:

• Analysis using historical control or RWD (e.g., registry, medical healthcare records, or claims data)

• Utilizing R to perform simulations and generate graphics; understand different R environments

• Proven successful project management leadership skills

• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills

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 $200,000 to $245,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

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

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.