Biostatistician 2

MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together we support innovation from concept to commercialization offering expertise in regulatory strategy clinical trial design and execution market access and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech.

Overview

The Biostatistician 2 is a critical biostatistics team member that will be responsible for research design and analytical/statistical strategies. This individual will provide input into protocols and project design develop and review statistical analysis plans and author or co-author various statistical outputs which include summary reports abstracts charters and manuscripts. The Biostatistician will utilize their expertise to provide input on the quality control of statistical deliverables and outputs. The Biostatistician will be client-facing at times and an important subject matter expert in the study team. This position will regularly collaborate with MCRA an IQVIA businesss Clinical Regulatory and Data Management teams as well as external partners and clients.

Responsibilities and Duties

• Develop analysis strategies and execute them using efficient programming techniques utilizing SAS and/or R.

• Provides appropriate statistical input for clinical protocol design and regulatory submissions and responds to statistical questions raised by regulatory agencies.

• Develops statistical analysis plans including the definition of derived data sets and the design of templates for statistical tables figures and/or data listings for clinical summary reports.

• Responsible for statistical aspects of projects including experimental design analysis and presentation of data. Maintains consistent approaches within and across research projects.

• May serves as a Lead Biostatistician responsible for management of statistical tasks related to assigned projects.

• Able to assist with DSMB charter review and development communicate blinded and unblinded summaries to DSMB members sponsors and regulatory agencies.

• Able to research and apply new statistical procedures and methods as needed.

• Responsible for the accuracy quality and completeness of analyses conducted for assigned projects. Monitors and verifies statistical analysis programs written by junior statisticians and programmers.

• Conducts statistical analyses and interprets results prepares statistical summary reports.

• Writes the statistical methods sections of integrated study reports. Reviews and approves draft integrated study reports.

• Manages statistical projects with high quality within budget and on-time completion.

• Establishes and maintains effective working relationships with clients and MCRA an IQVIA business project team members (internal and external) including Data Management personnel Statistical Programmers and Clinical Research personnel.

• Participates in presentations at client and investigator meetings.

• Assist in business development functions (i.e. provide insight on BD calls bid defenses etc.) to secure new clients and projects and be a proactive advisor for all types of analysis from the proposal process through the project life cycle.

• Interface with client/sponsor organizations as a representative of the biostatistical and statistical programming team in team meetings.

• Work collaboratively with other MCRA an IQVIA business departments including clinical and regulatory to support their needs in terms of biostatistical resources and support.

• Technical writing and review of documents and deliverables.

• Represent MCRA an IQVIA business at conferences and meetings as needed.

• Complete other duties and projects as assigned.

• Ensure all work products comply fully with SOPs regulations standards policies and the mission of MCRA an IQVIA business.

Required Knowledge Skills and Experience

• Education: Bachelors degree in Statistics Biostatistics Epidemiology or other relevant degrees.

• Certification/Licensure: Not applicable.

• Experience: 1-3 years of biostatistics experience related to clinical trials and regulatory affairs in the medical device space.

• Other:

• Knowledge of data standards for clinical research and statistical analysis including CDISC SDTM ADaM and ICH Statistical Principles for Clinical Trials.

• Proficiency with SAS - R and Python skills are a plus.

• An understanding of quality control as it relates to regulatory documentation requirements is preferred.

• Ability to read analyze and interpret complex documents.

• Strong research analytical critical-thinking and problem-solving skills.

• Must be able to manage multiple projects and deliverables simultaneously and generate meaningful results.

• Ability to adapt to a rapidly changing environment and quickly identify new trends and changes specific to the industry.

• Strong professionalism with customer relations and managing client relationships.

• PC/Technical skills: strongly proficient in MS Office Suite Excel Word PowerPoint.

• Excellent oral and written communication skills and presentation skills.

• Ability to lead a team and mentor junior team members and share knowledge.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.