Director Clinical Data Science / Biostatistics

Hybrid role in Irvine 3 days office 2 remote (preferred) OR full remote (possible)Relocation offeredAbout the job The Director, Clinical Data Science will lead a team of statisticians and data managers.
This individual will be accountable for the development and execution of statistical strategy in accordance with applicable regulations for pre- and post market clinical trials across Neurovascular in addition to preclinical trials.
S/he ensures statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets.
In addition, this individual is responsible for overseeing the execution of data management processes of new and ongoing clinical trials from startup through study maintenance and close-out phase in line with Company SOPs and best practices, reporting and escalating to senior staff as appropriate.
Location: Preferred job location: Irvine, California.
Remote candidates will be considered on a case-by-case basis or Relocation will be provided   Key Responsibilities: Provide leadership and direction for Biostatistics, Programming and Data Management including management and mentoring of staff to provide expert statistical and data management capability Develop and maintain global harmonized processes and procedures for Biostatistics, Programming and Data Management according to applicable laws and regulations Provide statistical direction to staff for study design, protocol development, analyses and publication strategy for both preclinical and clinical trials Work with BPDM partners, and leadership in Clinical to set priorities, develop project management plans for trial execution including timelines, milestones, and budgets Provide leadership to Clinical Data Management and Programming and ensure adoption of appropriate data and programming standards Lead vendor evaluation, selection, contracting, and oversight activities for Biostatistics, Programming and Data Management Interact with regulatory agencies to support the review process of statistical methodology employed in clinical trials Stay current with statistical research and the use of novel methodology in clinical trial design and analysis Provide oversight of data management services for a portfolio of studies from study start-up through close-out, ensuring Data Management team executes against project plans Provide oversight of data management processes for clinical trials Supervise, train, mentor, and develop Data Management team Drive process improvements, implement corporate goals and objectives, ensure Data Management and Programming can meet the needs of the business   Desired Skills and Experience A PhD in Statistics with at least 8 years of experience in clinical research within Medical Device or Pharmaceuticals is required.
A minimum of 3 years of experience leading statistical teams is required.
Therapeutic area knowledge in neurovascular preferred.
Demonstrated technical leadership in delivering critical milestones required.
Experience with survival analysis, longitudinal data analysis, and frequentist and bayesian adaptive designs preferred.
Excellent verbal and written communication skills required.
Experience interacting with regulatory agencies required.
Experience programming with SAS or R required.
Meet Your Recruiter Sean GouldingVice President – Technical Recruiting, Skilled Labor, Accounting And Finance Sean has over 8 years’ experience with Mattson Resources and over 20 years in executive search, technical recruiting, and staffing.
With a Bachelor’s in Business Administration and a concentration in Human Resources as well as 16 years agency experience and 4 years corporate in staffing – Sean and his team can assist in all areas of search for your hiring needs.
In agency search, Sean has led teams and recruiting services for Engineering, Sciences, IT, Skilled Labor, Operations, Supply Chain, Operational Excellence and more for Medical Device, Pharma, Aerospace, Automotive, Distribution, Transportation, IT Services, Software, Food & Beverage, Retail, and Consumer Products.
In 2021 Sean oversaw Mattson Resources expansion and opening of a satellite office in Corona, CA.
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