Manager, Biostatistician

Company: Edwards Lifesciences
Location: Irvine
Posted on: March 18, 2023

Job Description:

Manager, Biostatistician, Hybrid in Irvine, CA or Remote, USA, Transcatheter Mitral & Tricuspid Therapies 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.Key Responsibilities:

• 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
• Collaborate 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
• Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
• Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team
• Compile technical documents for internal and external audits
• Contribute 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)
• Collaborate on developing case report forms and clinical database to ensure quality data collection
• Lead the efforts of data analysis for data monitoring committee as neededEducation and Experience:
  • Master's Degree or equivalent in in Statistics, Biostatistics, or related field, PLUS 5 years of previous analytical experience in clinical trials Required OR
  • Ph.D. or equivalent in Statistics, Biostatistics, or related field , PLUS 2 years of previous analytical experience in clinical trials RequiredAdditional Skills:
    • 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
    • Keeps abreast of new developments in statistics and regulatory guidance
    • Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
    • Proven expertise in SAS
    • Experience using other software packages (e.g., R, S-Plus)
    • Extensive 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
    • Strong leadership skills and ability to influence change
    • Ability to provide training and coaching to lower level employees
    • Experience in facilitating change, including collaboration with management and executive stakeholders
    • Strict attention to detail
    • 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 serving as consultant to management
    • Ability to interact with suppliers, vendors and/or customers
    • 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/controlAligning 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.The base pay range for this position is $123,000 to $174,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).

Keywords: Edwards Lifesciences, Irvine , Manager, Biostatistician, Executive , Irvine, California