Senior Manager, Statistical Programming

🕒 il y a 3 jours

🏄 California – Distant

🏄 California – Remote

💵 $151 000 - $215 000 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

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Edwards Lifesciences

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1958

🏥 Santé

💼 Conseil

🍽️ Alimentation et boissons

Healthcare • Consulting • Food & Beverage

Edwards Lifesciences est un leader mondial dans les innovations médicales centrées sur le patient. L'entreprise se spécialise dans les solutions pour les maladies des valves cardiaques, en proposant des produits et services tels que les valves cardiaques transcathéter et les technologies mitrales et tricuspides, ainsi que des solutions de valves cardiaques chirurgicales. Edwards Lifesciences se concentre également sur les technologies de soins critiques, incluant la surveillance hémodynamique, la surveillance à distance et la surveillance prédictive. L'entreprise mène des recherches cliniques et s'engage à améliorer la vie des patients grâce à des solutions innovantes pour les maladies cardiovasculaires, tout en étant un citoyen d'entreprise responsable, avec un accent sur les dons d'entreprise à l'échelle mondiale.

Description

• Lead clinical studies, manage a team, and oversee statistical programming activities • Lead programmers in developing program specifications and design documents with the project statistician • Lead programming of analysis datasets across multiple clinical trials • Serve as lead statistical programmer for specific projects as needed • Manage and oversee a team of statistical programmers and matrix teams as appropriate • Develop a talent development plan aligned with departmental functional growth strategies • Provide programming expertise for clinical-trial analyses used in clinical study reports, presentations, and select publications • Provide programming expertise for complex ad hoc data requests • Identify risks and lead implementation of mitigation strategies, including negotiations with internal and external parties • Ensure analysis data and programming code meet regulatory and company standards • Ensure databases and external data sources meet analysis requirements across clinical trials • Develop and revise statistical programming procedures or instructions • Assist in compiling technical documents for internal and external audits • Perform other duties assigned by Leadership • Collaborate with cross-functional teams, customers, functional peer-group managers, and internal and external representatives • Participate in and present at internal and external meetings

🎯 Exigences

• Bachelor's Degree in Statistics, Mathematics, Computer Science or related field with 10 years previous experience in statistical analysis, or 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 • Class III Medical Device Experience preferred • SDTM, ADAM, TLF, Macros Experience preferred • Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel preferred • Excellent written and verbal communication skills and interpersonal relationship skills, including negotiating and relationship management skills • 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 • Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to pharmaceutical/medical device research • Demonstrated track record in people management • Excellent problem-solving, organizational, analytical, and critical thinking skills • Demonstrated ability to manage an assigned team and provide coaching and feedback, including hire/fire authority and partnering with HR on employee relations • Experience facilitating change and collaborating with management and executive stakeholders • Ability to interact professionally with all organizational levels • Ability to manage competing priorities in a fast-paced environment • Ability to work in a team environment, including participating and presenting at meetings with external representatives • Ability to adhere to company rules and requirements, including pandemic protocols and Environmental Health & Safety rules • Ability to prevent injuries and pollution within area of influence/control

🏖️ Avantages

• Competitive salaries • Performance-based incentives • Wide variety of benefits programs to address the diverse individual needs of employees and their families