Company Overview
Founded in 2004, MCRA is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients.
MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1100 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.
Overview
The Biostatistician will serve as a critical team member that will lead research design and analytical strategies, 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. Under the leadership of the VP, Head of Operations and Scientific Regulatory Affairs, the Biostatistician will utilize their expertise to advise, provide guidance, and to oversee the quality control of statistical deliverables and outputs.
As a functional lead or contributor within a study team, they will lead or contribute to Biostatistical activities on a study and are accountable for deliverables. The Biostatistician is a client-facing participant and an important subject matter expert in the study team.This position will regularly collaborate with MCRA’s Clinical, Regulatory, and Data Management teams, as well as external partners and clients. The ideal candidate will be a self-starter that is passionate about delivering high value and assisting device and MedTech manufacturers with their statistical needs in regulatory clinical trials.
Responsibilities and Duties
- Develop analysis strategies and execute them using efficient programming techniques utilizing SAS and/or R.
- Provides appropriate statistical input for 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.
- Serves as a Lead Biostatistician responsible for management of statistical tasks related to assigned projects and share knowledge.
- 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 other 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 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 departments, including clinical and regulatory to support their needs in terms of biostatistical resources
- Technical writing and review of documents and deliverables.
- Represent MCRA 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.
Required Knowledge, Skills, and Experience
- Master’s Degree or PhD in Statistics, Biostatistics, Epidemiology, or other relevant degrees.
- 4-7+ years of experience in biostatistics experience related to clinical trials and/or regulatory affairs.
- Experience within the CRO, medical device, or pharmaceutical industry is preferred.
- Experience and familiarity with orthopedic medical devices is highly preferred.
- 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.
- Experience with adaptive trials and Bayesian analysis techniques is desired.
- 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.
- 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.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.
MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
Apply for this job
