Manager, Biostatistics, TMTT, Remote US

Manager Biostatistician - Transcatheter Mitral & Tricuspid Therapies (Remote- US)

This is an exciting opportunity for an exceptional biostatistician professional with extensive experience to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up.

TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives.

The Manager Biostatistician will represent the 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.

Please note that this is a highly technical individual contributor position.

You will make an impact by...

Taking charge as statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses

Collaborating with core stakeholders to provide statistical expertise in support of new product development (NPD) and / or regulatory submissions (e.

g., PMA, CE Mark, PMDA) and other regulatory documents as needed

Representing Biostatistics on project / study teams and coordinate / communicate with management and other team members regarding project / study status and timeline update

Providing statistical expertise on ad hoc data analysis requests and publication / presentation efforts related to the project team

Compiling technical documents for internal and external audits

Contributing 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)

Collaborating on developing case report forms and clinical database to ensure quality data collection

Leading the efforts of data analysis for data monitoring committee as needed

What you'll need (Required) :

Master's Degree or equivalent in Statistics, Biostatistics, or related field, Plus 5 years of previous analytical experience in clinical trial design Required or

Ph.D. or equivalent in Statistics, Biostatistics, or related field , Plus 2 years of professional experience in clinical trial design Required

What else we look for (Preferred) :

Experience as a biostatistician working in the medical device setting preferred

Experience with trial simulations for sample size and power calculation

Extensive understanding in statistical methodologies related to clinical trial designs, statistical modeling, data analyses, development SAP, SOPs, WIMs

Extensive understanding of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to the Medical Device research setting;

Stays up to date with industry trends

Experience writing CERs under strict timelines

Experience with Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB)

Can effectively manage competing priorities in a fast paced environment and maintain strict attention to detail

Excellent written and verbal communication skills and interpersonal skills / capabilities including the following : self-driven, negotiation, leadership, relationship management

Demonstrates Leadership capabilities including ability to provide training and coaching to more junior level employees and interaction with suppliers, vendors and / or customers

Experience in facilitating change, including collaboration with all organizational levels including executive stakeholders;

ability to influence change

Excellent problem-solving, organizational, analytical and critical thinking skills

Proven expertise in SAS; Experience with other software packages (e.g., R, S-Plus)

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

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.

For California, the base pay range for this position is $130,000 to $170,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., 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 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.