Senior Director, Statistical Programming (Southern California Hybrid) TMTT

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: May 21, 2023

Job Description:

This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.The Senior Director, Statistical Programming manages a team and oversee statistical programming activities.Key Responsibilities including but not limited to:

• Set overall functional programming support strategy. Negotiate service levels (project scope and timelines) with cross-functional partners. Direct and communicate highly complex statistical programming strategies which includes negotiations with internal and external parties
• Plan and direct strategic activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives. Oversee the development of formal statistical outputs, including Standard Data Sets, Tables, Listings, and Graphs
• Direct activities with overall responsibility of developing systems, planning, staffing, budgeting, managing expense priorities, recommending and implementing changes to methods through manager(s) and SMEs
• Lead the development and implementation of programming standards
• Develop a robust talent development and succession plan in alignment with functional growth strategies across the global statistical programming organization
• Identify functional gaps and recommend process improvements
• Prepare and approve key SOPs in programming area. Oversee the creation and maintenance of statistical programming SOPs and procedures to ensure the compliance to regulations and company policies
• Identify and mitigate clinical, quality, and regulatory risks, ensure high quality and timely deliverables, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional teams
• Analyze, formulate and present recommendations to advise and guide internal and external stakeholders; develop and deliver executive level communication
• Serve in a leadership role within external associations as appropriate -Required Qualifications:
  • Master's Degree or equivalent in Statistics, Mathematics, Computer Science or related field
    • Previous experience in statistical analysis
    • Demonstrated track record in people management
    • Proven expertise in SAS and Windows operating systems
    • Ability to travel up to 10%Preferred Qualifications:
      • Experience working in a regulated industry
      • Experience using other software packages (e.g., R, S-Plus)Additional Skills:
        • Proven successful project management leadership skills
        • Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
        • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
        • Expert understanding of statistical programming procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems
        • Expert understanding of related aspects of statistical programming processes and/or systems
        • Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
        • Demonstrated ability to direct 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
        • Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT
        • Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
        • Ability to develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness
        • Ability to provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions
        • 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/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.

Keywords: Edwards Lifesciences Gruppe, Irvine , Senior Director, Statistical Programming (Southern California Hybrid) TMTT, Executive , Irvine, California