Director, Biometrics - San Diego, CA | Biospace
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Director, Biometrics

Dart NeuroScience LLC

San Diego, CA
Posted Date:
Position Type:
Full time
Job Code:
17-044 #808648
Required Education:
Masters Degree
Areas of Expertise Desired:
Biostatistics, Clinical Data Management, Statistics,

Job Description

Serve as the Head of Biometrics, consisting of data management, programming and biostatistics.  Oversees biometrics function, ensuring system, capabilities and resources for the department in the conduct of clinical trials.  The Director provides statistical, programming and data management direction to executives, employees, managers/directors and contractors related to the biometrics departments. Work in a cross-function manner with other managers and directors in Clinical R&D, Clinical Operations, CMC, DMPK and Regulatory Affairs functions relating to the design, conduct, analysis and reporting of clinical trials in support of Phase I-IV clinical development and regulatory submission programs -- with an initial focus on early clinical development.  Ensures the appropriate allocation of resources for biometrics.  Determine staffing needs, recruitment of staff and evaluation of performance. Facilitate a matrix team type approach, partners with functional leaders from Clinical Science, Regulatory Affairs, and Clinical Operations as well as other departments as necessary. Provide leadership and best practices to the department, facilitating knowledge sharing and overall standards, quality and processes. Ensure strategic input and technical expertise on statistical methodologies for program development.

•   Work closely with management and colleagues (other Biostatisticians, Clinical Scientists, Regulatory, Data Management, Statistical Programmers, Medical Writing, Safety and Clinical Operations) in identifying technology needs, gaps or approaches to mitigate risk to ensure optimal functioning of biometrics
•   Review and approve protocols, SAPs and may prepare statistical methods section(s), including sample size estimation and clinical endpoint assessments, to ensure DNS conducts well designed, efficient, cost-effective, as well as statistically valid clinical trials and/or ensures that senior biostatisticians conduct this activity successfully
•   Acts as the primary contact for biometrics vendor CRO management for biostatistics, data management and programming related activities, coordinating with clinical operations and other directors in biometrics
•   Responsible for ensuring that the appropriate resources are assigned to data management, programming, database set-up, UAT, protocol and SAP design, CDISC SDTM/ADAM specifications and review and Clinical Study Report input
•   Facilitate and review data, programming and statistical standards for data collection strategies and instruments (CRFs), clinical information systems and programming, database design, edit check specifications, external data transfer specifications, User Acceptance Testing (UAT), protocol, SAP and TFL templates, randomization, blinding/unblinding and ensures that adequate resources are assigned to these activities
•   Supervise the work of biostatisticians in the review and/or creation of detailed Statistical Analysis Plan (SAP) including development of well-presented mock-up displays for tables, listings and figures (TLFs), conduct data analyses and oversee preparation of all tables, listings and figures (including review of work by programmers), as well as preparation of a formal statistical report as needed
•   Provide strategic guidance in the preparation of Regulatory Authority documents (clinical study reports, submissions, clinical protocols, safety reports, etc…)
•   Review and sign-off on protocols and SAPs, SOPs and work practices for department. Give statistical guidance to clinical and data management functions on endpoints.
•   Ensure the accurate interpretation of clinical trial data internally and to health authorities, healthcare providers, etc…
•   Participate in Clinical Development Leadership Team, program and governance committees and senior management meetings.
•   Review IVRS/IWRS specifications and sign-off on critical study documents
•   Mentor and coach direct reports


•   MS/MPH or PhD (PhD equivalent) in biostatistics or statistics or public health
•   15+ years of relevant industry experience  (15+ yrs for MS/MPH or 10+ yrs for PhD) and prior management experience
•   Familiar with FDA and ICH guidance and regulations as they relate to biostatistics, data management and GCPs with preference for interaction with regulatory authorities (FDA/EMA including Advisory Committee Meetings)
•   Experience working with CRO’s/technical vendors and overseeing compliance with standards, output and adherence to statistical sections of protocol and SAP
•   Experience with PK/PD, safety and efficacy data as it relates to GCP clinical trials
•   Experience with managing budgets and timelines with strong business acumen and critical thinking
•   Solid understanding of statistical methods and current data management practices
•   Understanding of CDISC/ADAM specifications
•   In-depth experience with SAS statistical methods, management of biostatistics, data management and statistical programming
•   Ability to work in a fast-paced environment
•   Create and facilitate creation and maintenance of departmental SOPs and work practices

Preferred Experience:

•   Ability to set and monitor departmental timelines and adjust to changing needs
•   Strong team work and communication skills
•   Prefer experience with CNS, mixed effects modeling, handling of missing data and longitudinal analysis
•   Familiarity with CDISC