Director, Biostatistics (Remote, USA)

Edwards Lifesciences' trailblazing Transcatheter Mitral & Tricuspid Therapies (TMTT) division is looking for a Director , Biostatistics to be based in either the Irvine, CA area or remotely within the United States.As a Director, Biostatistics, you are responsible for a team of biostatisticians while ensuring the proper design, analysis and presentation of clinical studies.Key ResponsibilitiesAct as core team member and lead biostatistician of assigned clinical trials

Accountable for clinical trials assigned to direct reports

Manage and oversee the work of biostatistics team and may indirectly manage cross functional or matrix teams

Provide technical/statistical leadership to multiple and/or complex clinical projects in collaboration with cross-functional teams

Provide statistical insight/strategies to study design for complex clinical studies

Develop a robust talent development plan in alignment with functional growth strategies of the department

Develop and lead the implementation of biostatistics strategies which may include negotiations with internal and external parties

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

Create, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency and optimization

Manage activities with accountability for successful completion of all deliverables

Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams

Provide statistical expertise to internal and external stakeholders (e.g., presentation/publication, Marketing, Health Economics & Reimbursement)

Make resource planning and budgetary recommendations on operational expenditure planning and other financial activities

Minimum QualificationsPh.D. in Biostatistics or Statistics with minimum 8 years of previous analytical experience in clinical trials OR

Master’s degree in Biostatistics or Statistics with minimum 11 years of previous analytical experience in clinical trials

Must be proficient with SAS or R

Demonstrated ability to manage assigned team and providing coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations

Preferred QualificationsAdaptive design and Bayesian analysis experience

Proven track of successful experience in NDA/IDE/PMA/PMDA/CE mark submissions

DMC/DSMB experience

Experience using PASS or EAST

General ExpectationsExpert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems

Expert understanding of related aspects of biostatistics processes or systems

Expert understanding and knowledge of regulatory guidelines (GCP, ICH, FDA, ISO) relevant in pharmaceutical/medical device research setting

Capable of independently leading pivotal trials

Experience in trial simulations for sample size and power calculation

Familiar with survival, regression and categorical data analysis methods

Proven successful project management leadership skills

For Colorado Residents OnlyAligning 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 $178,000 to $208,000

Additional information can be found at https://www.edwards.com/careers/benefits

#LI-REMOTEEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.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 or have a valid religious or medical exemption from being vaccinated.