Senior Clinical Database Programmer

MacroGenics

Posted on: July 25, 2024

Closing: August 24, 2024

Position Type: Full Time

Job Description

Why ImmunityBio?
• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.

Position Summary

The Senior Clinical Database Programmer will design, program, and test Electronic Data Capture (EDC) databases for the purpose of conducting clinical studies.   The role works with Clinical Study Teams to develop EDC databases in adherence to departmental Standard Operating Procedures (SOPs).

 

Essential Functions

  • Lead EDC database development in consultation with Clinical Data Managers, Statistical Programmers, Biostatisticians, and Clinical Trial Managers.
  • Design, program, and test EDC databases including eCRFs, dictionaries, data validation checks, database functions (including new), and standard and custom database reports.
  • Develop and maintain a global library according to current (CDISC/SDTM) and new standards.
  • Assist with EDC database User Acceptance Testing.
  • Develop and maintain EDC database documentation.
  • Provide EDC technical support to facilitate study timelines and deliverables.
  • Conduct training on EDC database usage to support internal and external users.
  • In conjunction with the Senior Director of Data Management, coordinate EDC database software validation efforts.
  • Maintain Coding Dictionary updates/version control within the application
  • Serve as a resource for Clinical Data Management SOP development and best practices in an effort to improve quality and streamline EDC database build and data cleaning efforts.
  • Serve as point of contact for Clinical Database Programmers inclusive of training and mentoring as needed.
  • Performs other duties as assigned.

 

Education & Experience

  • Bachelor’s Degree in a science-related field
  • 6+ years of clinical database programming experience
  • Substantial experience with EDC database development

 

Knowledge, Skills, & Abilities

  • Proficiency in SAS programming language.
  • Knowledge of CDISC/SDTM standards.
  • Knowledge of TrialMaster and/or Veeva Vault CDMS EDC systems preferred.
  • Experience with clinical coding dictionaries including MedDRA and WHODrug.
  • Working knowledge of Good Clinical Practices and regulatory requirements including FDA regulations 21 CFR Part 11.
  • Proficiency in computer skills across multiple applications.
  • Strong English verbal and written communication skills; good organizational and interpersonal skills.

 

Working Environment / Physical Environment

  • This position works remotely
  • Moderate use of telephone, teleconferencing and face-to-face communication requiring accurate perception of speech.
  • Substantial use of keyboard requiring repetitive motion of fingers and regular sitting for extended periods of time.
  • Minimal travel is required for training and company meetings

 

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below.  The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

 

$115,000 (entry-level qualifications) to $158,000 (highly experienced) annually

 

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

 

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day•  We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

MacroGenics

Posted on: July 25, 2024

Closing: August 24, 2024

Position Type: Full Time

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