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.
How you’ll make an impact:
Lead on clinical studies and manage a team and oversee statistical programming activities.
Lead a team of programmers in the development of program specifications and design documents in partnership with project statistician. Lead in programming analysis datasets in multiple clinical trials. May also function as a lead statistical programmer for specific projects as needed.
Manage and oversee the work of a small team of statistical programmers and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department
Provide programming expertise on multiple clinical trials for analysis for inclusion in clinical study reports, presentations, or select publications in collaboration with project statistician
Provide programming expertise on complex ad hoc data requests in collaboration with project statistician
Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties
Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review
Lead a team of programmers in collaboration with cross-functional teams to ensure that database and external data source when applicable meet analysis requirements across clinical trials
Develop and revise statistical programming procedures or instructions
Assist in compiling technical documents for internal and external audits; Other duties assigned by Leadership
What you'll need (Required):
Bachelor's Degree in fields of Statistics, Mathematics, Computer Science or related field with 10 years previous experience in statistical analysis
Master's Degree with 8 years working in a regulated industry
Proven successful project management leadership skills
Proven expertise in SAS and Windows operating systems required; experience using other software packages (e.g., R, S-Plus)
What else we look for (Preferred):
Class III Medical Device Experience
SDTM, ADAM, TLF, Macros Experience
Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Keeps abreast of new developments in statistics and regulatory guidance
Expert understanding of clinical trial and statistical programming procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
Demonstrated track record in people management
Expert understanding and knowledge relevant to statistical programming
Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
Excellent problem-solving, organizational, analytical and critical thinking skills
Demonstrated ability to manage assigned team 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
Experience in facilitating change, including collaboration with management and executive stakeholder
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including participating and presenting at meetings, including with external representatives
Frequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team
Participate and present at meetings with internal and external representatives
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 $151,000 - $215,000 (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.
Originally posted on Himalayas
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.