Senior Clinical Database Programmer
El Segundo, CA  / Mariposa, CA 
Share
Posted 4 days ago
Job Description

ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company's immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory." The U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio's resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guerin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease, and has set a user fee goal date (PDUFA date) of April 23, 2024.

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 an early-stage public biopharmaceutical company with a headquarters in Southern California.

* Work with a collaborative team with the ability to work across different areas at the company.

* Ability to join a growing company with 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 on site
  • 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.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
6+ years
Email this Job to Yourself or a Friend
Indicates required fields