- Home-based remote working opportunities
- Work/life balance as well as flexible schedules
- Collaborating with dedicated, high-performance, statistical and research teams
- Variety of therapeutic areas, indications and, study phases
- Technical training and tailored development curriculum
- Research opportunities that match your unique skillset
- Promising career trajectory
- Job stability: long-term engagements and re-deployment opportunities
- Focus on bringing new therapies to market rather than project budgets and change orders.
- Interact with members of the multidisciplinary project teams to establish project timelines.
- Provide statistical input to study protocols.
- Write statistical analysis plans.
- Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
- Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.
- Collaborates with Data management, Clinical Development, and Clinical Operations on design of eCRFs.
- Collaborates with Statistical Programmers on summary and analysis of trial data. Writes ADS and ad hoc analysis specifications.
- Contributes to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, etc.
- Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures.
- Interpret study results and provide review of statistical summary reports of study results for accuracy.
- Participate and contribute to authoring of Clinical Development Plan.
- Participate in pre-IND and NDA activities.
- Participate in the development and enforcement of SOPs and guideline.
- Participates in other activities and meetings to support Biostatistics and the Development Team as needed.
- Consults with Research & Preclinical colleagues on statistical questions in their work.
- PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
- MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
- 3-5 years of strong experience in Oncology Therapeutic Area and Submissions.
- Cardiovascular & Metabolic Therapeutic Area are also preferred.
- Experience with Therapeutic areas under rare diseases preferred.
- Good to have knowledge or Experience in R
- Strong Bayesian method is preferred.
- Demonstrate ability to work independently in project management and decision making.
- Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
- Ability to use SAS and/or R to perform efficacy analyses and validate important data derivations when necessary.
- Experience with simulations.
- Understanding of ICH GCP as well as general knowledge of industry practices and standards.
- Familiarity with R programming language and other statistical software, including EAST.
- Experience with CDISC, including SDTM, ADaM, CDASH.
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Senior Biostatistician - Durham, United States - IQVIA
Description
Job Level: Senior Biostatistician within DSSSLocation: Home-based in the U.S. or Canada
Why DSSS?
Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading global CRO while operating within a sponsor environment and utilizing sponsor systems. These sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies.
Job Summary:
The Senior Biostatistician is responsible for providing statistical support for drug development programs in all phases of development.
Additional Benefits:
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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.
IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.
The potential base pay range for this role, when annualized, is $122, $233, The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
