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
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