Principal Statistical Programmer

We are seeking a Clinical Programmer to work remotely for a client project. Experience with Metadata and C# is required. No 3rd party (C2C) can be considered.

Overview

Summary: The main function of the Prin, Clinical Programming is to design, develop, and maintain clinical databases in EDC systems to support business requirements.

Job Responsibilities

• Provide technical expertise in clinical programming functional area and lead in the development of clinical databases. Development includes tools and programs for data validation checks, custom functions (C#) and clinical trial reporting in collaboration with key stakeholders.
• Lead cross functional teams in the design and delivery of complex functional modules (e.g. TSDV, BO4 etc.) and provide clinical programming expertise regarding clinical trials, protocols, and case report forms.
• Lead the development of specifications for systems and/or processes, system upgrades/enhancements and integration; and engage IT to deliver higher level support to users.
• Develop and present high level technical training to end-users, including providing guidance to lower-level Clinical Programmers in their training program development.

Qualifications

• Bachelor's Degree or higher related field with 8-10 years of previous related experience in clinical research database programming, data management, software programming or related field or equivalent work experience based on Edward's criteria (Required).
• Deep subject matter expertise in Medidata EDC including C# custom function development.
• Proven successful project management skills.
• Proven expertise in both Microsoft Office Suite, including advanced Excel and CDM (Clinical Data Management) systems.
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
• Good presentation and facilitation skills.
• Ability to translate technical information to cross-functional teams.

Soft Skills

• Strong team orientation with the ability to collaborate effectively across cross-functional clinical teams.
• Willingness to balance high-level technical work with detailed documentation and administrative responsibilities.
• Ability to work with a sense of urgency and contribute quickly in a fast-paced environment.
• Clear and proactive communication, especially when working with distributed teams.

Top Priorities for Success in Role

• Candidates must demonstrate hands-on experience in the following areas:
• Medidata Rave (Metadata) - New Study Builds (required)
• Strong Medidata database experience required with C# custom function experience needed.
• TSDV (Targeted Source Data Verification module)
• Custom Functions (must have hands-on development experience)
• Advanced Edit Checks/Data Validation Logic

Candidates without direct experience in these areas, particularly custom function development within Medidata, will not be considered for this level.

Exceptional Candidate Consideration: For candidates who demonstrate significantly advanced experience, senior-level expertise, and full alignment with all required technical competencies, there may be flexibility to consider submission up to a higher bill rate.

This applies only to candidates who:

• Meet all required qualifications
• Demonstrate deep expertise (e.g., advanced custom functions, metadata study builds, TSDV advanced edit checks)
• Are operating at a Principle to Senior Principal level

Additional Role Considerations:

• Time Zone Preference:
• Pacific Time Zone preferred to align with the core team.
• Fully remote candidates will be considered.
• Conversation to full-time may require alignment with hybrid expectations, provided that the opportunity presents itself.

Desired Skills and Experience

metadata and C#, clinical programming

EEO Notice

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.