Associate Director, Clinical Programming

Location
Brisbane, California, United States
Posted
Oct 11, 2020
Ref
411078527
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SUMMARY:

We are seeking an Associate Director, Clinical Programming to join the Clinical Data Management (CDM) team within the Biometrics function. This position will be responsible for building in-house clinical programming infrastructure and capabilities to support data quality assurance processes and operational efficiency within CDM. This position will report into the Executive Director, Clinical Data Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Develop and support in-house clinical programming capabilities
  • Recruit, train and mentor clinical programing staff
  • Generate outputs including, but not limited to: CDM data and query metrics, patient profiles, clinical data listings and reports across multiple studies/clinical programs, and clean patient tracking.
  • Generate reconciliation programs to ensure consistency between clinical data management system (CDMS) and external databases
  • Generate data visualizations for CDM using Spotfire or other visualization tools
  • Participate in the implementation of a clinical data warehouse
  • Automate data transfer and reporting processes to enhance CDM operational efficiency
  • Create and maintain clinical programming SOPs and guidance documents
  • Develop and maintain a standard library of clinical programs to support data quality review
  • Assist in the development of standard external data transfer specifications
  • Review clinical data transfers for consistency with available specifications and/or data transfer plans
  • Convert raw non-SAS data files to SAS dataset
  • Provide other clinical programming support across Clinical Development projects
  • Assist with strategic planning activities for the CDM department and participate in the implementation of new departmental initiatives
  • Address clinical programing needs of CDM functional customers
  • Demonstrate a commitment to company values: Patient First, Passion for Science, Success Together, Imagine and Innovate, and Lifelong Learning


EDUCATION/EXPERIENCE/SKILLS:

Education:

  • Minimum of a Bachelor of Science degree in a scientific discipline or equivalent college program. Master's is preferred.


Experience:

  • 10+ years programming experience in the pharmaceutical/biotech or CRO setting.
  • Strong experience using various technologies such as SAS, SQL, and Spotfire


Knowledge/Skills/Abilities:

  • Strong working knowledge of CDISC standards (CDASH, SDTM), FDA and ICH-GCP guidelines, and recommended CDM Best Practices.
  • Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities.
  • Ability to thrive in a fast-paced environment and adapt to changing business conditions with a "can-do" attitude.
  • Ability to work effectively in both a team setting and independently.
  • Strong interpersonal, organizational, and communication (written and verbal) skills.
  • Desire to be part of a values based, highly innovative cardiovascular company aimed at transforming the lives of patients and their families.