Director, Head of Biostatistics and Data Management

Location
Durham, NC
Posted
Nov 12, 2018
Ref
DBD
Required Education
Masters Degree/MBA
Position Type
Full time

Improving quality-of-life through innovations in urology. 

Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. 

Every employee at Urovant plays an integral role to our success.  We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve.  Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.

Urovant's lead product candidate, vibegron, is a β3-adrenergic agonist being developed for an oral, once-daily treatment for overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. 

Urovant's second investigational product candidate, hMaxi-K, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.

The Director, Head of Biostatistics and Data Management will be responsible for scientific-statistical integrity of the statistical planning and analyses for Urovant development projects and for the maintenance of the clinical data base. 

Responsibilities include:

  • Works collaboratively with clinical team leaders and global project teams on the statistical and data aspects of the development projects, including the development plans, clinical study protocols and clinical study reports.  Authors the statistical analysis plans for all Urovant development projects, including for global regulatory submissions for approvals.
  • Oversees the data management activities and statistical programming and analyses, including working with contract research organizations.
  • Contributes to due diligence activities, including development plans. 
  • Responsible for exploratory analyses for historical studies, analyses for due diligence activities, and quality checks of ongoing clinical studies, as requested.
  • Manage roles reporting to this position, including review of performance and working on training needs for further development of the direct reports.
  • Other responsibilities at management’s discretion.

Education and Experience

  • MS or PhD in Mathematics, Statistics, or Biostatistics.  
  • 8+ years of experience in statistical planning and analyses in clinical development of drugs and /or devices and NDA submission experience.
  • Experience in activities and working with data management, statistical programmers and statisticians in-house or at contract research organizations. 

Essential Skills and Abilities

  • A commitment to collaborative leadership, management, teamwork, delegation and the maintenance of a professional culture based on trust and mutual respect.
  • Excellent leadership capabilities for cross functional teams with proven successful track record of working in a matrixed organization and building strong relationships with other functions and contractors/vendors.
  • Strong interpersonal, reading, writing and communication skills, along with exceptional organizational skills.
  • Strong presentation skills, including presentations to senior management and external audiences and experts.
  • Strong problem and conflict resolution skills. 
  • Exceptional business acumen, analytical skills.
  • Ability to work on several projects and assignments at the same time and prioritize tasks.
  • Ability to develop and manage expenditures in accordance with budget. 
  • Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance and auditing including broad application of knowledge in different therapeutic areas.
  • Ability to work across locations and time zones.
  • Travel, including international travel, at least 25%, depending on business needs.

Learn more at https://urovant.com