IQVIA Senior Biostatistician (Office/Home-Based) - IQVIA Biotech in Morrisville, North Carolina
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Candidates Must have Lead experience in Oncology, CVD, Immunology or CNS in a CRO or Pharmaceutical setting preferred.
Provide statistical expertise and leadership to project and analysis team. Provide statistical consulting and technical support as it relates to the design and statistical analysis of clinical studies. Determine analysis and data presentation specifications for SAS Programming staff. Perform analysis, interpret study results, and collaborate with medical and biostatistics staff to produce interim reports and final reports. May be responsible for more than one study.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Collaborates with program staff on the implementation and analysis of statistical aspects of research protocols.
Provides statistical consultation for clinical programs, including but not limited to protocol development, randomization, sample size assessments, efficacy evaluations, and data review.
Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met for both internal and external clients.
Ensures that project tasks are completed with acceptable quality for both internal and external clients.
Coordinates with SAS programming staff to ensure the accurate programming of SAS clinical data extracts and data displays.
Develops statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays.
Reviews and provides comments on statistical summaries and analysis plans.
Develops programming specifications to summarize the results of clinical trials, including analysis datasets and tables/listings/figures.
Performs statistical analyses, including hypothesis testing and modeling.
Provides tabular and written summaries of analyses and statistical methodology for Clinical Study Reports.
Consults with sponsors regarding development of statistical analysis plans, protocol content and study design as dictated by the specific nature of the project.
Interacts with Medical Writers to ensure appropriateness of data inferences.
Writes pertinent sections of a clinical study report
Interfaces with clients and/or regulatory agencies as the project biostatistician.
Attends team meetings and represent departmental needs for assigned projects.
KNOWLEDGE, SKILLS AND ABILITIES:
Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
Experience with, and mastery of, statistical methods commonly used in the analysis of data obtained from Phase I – IV clinical trials.
Experience with SAS Base and SAS Stat, as well as strong data step skills.
Experience with other statistical software packages, such as N-Query, S-Plus.
Ability to work creatively and independently to carry out assignments of a complex nature.
Ability to work effectively and cooperatively with other professional staff members.
Ability to communicate effectively, both verbally and in writing, with all levels of staff and with the public.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very limited physical effort required to perform normal job duties.
MINIMUM RECRUITMENT STANDARDS:
Degree requirements include one of the following:
Masters-level degree in Statistics, Biostatistics or related field with four years relevant work experience; total work experience to include one year in CRO industry or biotech; or
Doctorate-level degree in Statistics, Biostatistics or related field with one year relevant work experience in CRO industry or biotech.
Data handling and analysis experience.
Excellent interpersonal and organization skills.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at email@example.com_ to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
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