Biostatistician 2

IQVIA•Washington, DC

10d

About The Position

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 business's Clinical, Regulatory, and Data Management teams, as well as external partners and clients.

Requirements

Education: Bachelor’s degree in Statistics, Biostatistics, Epidemiology, or other relevant degrees.
Experience: 1-3+ years of biostatistics experience related to clinical trials and regulatory affairs in the medical device space.
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.

Responsibilities

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.