Senior Statistical Programmer/Analyst Consultant - (remote in US)

ClinChoice

$110K — $130K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's or Master's degree in CS, statistics, or related field with 5-6 years' clinical programming (CDISC) experience.
  • Working knowledge of ICH, Good Clinical Practices, and clinical trial processes.
  • Expertise in the clinical drug development process.
  • Strong communication and coordination skills.
  • Up-to-date knowledge of technical and regulatory requirements for the role.
  • Proven ability to manage multiple project activities concurrently.
  • Effective in influencing stakeholders on programming issues.

Responsibilities

  • Support programming deliveries for clinical studies or projects.
  • Implement statistical programming for the protocol and clinical development program.
  • Ensure high quality in own and team deliverables.
  • Program independently with accuracy and efficiency.
  • Write and implement specifications, ensuring documentation completeness.
  • Develop best practices to enhance quality and efficiency in programming.
  • Ensure compliance with standards and promote automation in programming.
  • Plan and facilitate team activities and tasks.
  • Proactively communicate and escalate project risks to stakeholders.
  • Collaborate effectively with the study team, including Statisticians and Data Managers.

Benefits

  • Work directly with a single sponsor while benefiting from the stability of a global CRO.
  • Opportunity for professional growth and career advancement.
  • Access to a collaborative and experienced programming team.
  • Chance to contribute to best practices in statistical programming and clinical trials.
Full Job Description
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds....

ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients.

Main Job Tasks and Responsibilities:

The Senior Statistical Programmer Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks

Key Responsibilities:
  • Responsible for supporting the Programming deliveries of a clinical study or project.
  • Implements statistical programming aspects of the protocol and the clinical development program.
  • Ensures high quality is built into own deliverables and the quality delivered by other programmers.
  • Programs independently with high efficiency and quality.
  • Writes and/or implements specifications and oversees completeness of relevant documentation.
  • Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
  • Ensures compliance with standards and automation usage.
  • Plans and support team activities and tasks.
  • Communicates and escalates risks within the assigned studies and/or projects.
  • Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.

Education and Experience:
  • Bachelor's degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master's degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
  • Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
  • Good understanding of the clinical drug development process.
  • Strong communication skills and coordination skills.
  • Current knowledge of technical and regulatory requirements relevant for the role
  • Ability to proactively manage concurrent activities within a project
  • Proficient ability to influence relevant stakeholders on programming-related items

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

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