Senior Biostatistician; FSP

Senior Biostatistician (FSP) page is loaded## Senior Biostatistician (FSP) locations:
Durham, North Carolina, United States of America time type:
Full time posted on:
Posted Yesterday job requisition :
R1415443
** Job Level:
** Senior Biostatistician, FSP
*
* Location:

** Home-based in the U.S. or Canada 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.
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* Job Summary:

** The Senior Biostatistician is responsible for providing statistical support for drug development programs in all phases of development.
** Additional Benefits:
*** 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.
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* Job Requirements:

*** Validate Statistical outputs and datasets.
* Interact with members of the multidisciplinary project teams to establish project timelines.
* Provide statistical input to study protocols.
* Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.
* Write statistical analysis plans.
* Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
* Collaborates with Data Management, Clinical Development, and Clinical Operations on design of eCRFs.
* 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 review reports of study results for accuracy.
* Participate and contribute to authoring of Clinical Development Plan.
* Support exploratory analyses and medical affairs publications.
* 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.
** Qualifications** (Minimal acceptable level of education, work experience, and competency)
* PhD in Statistics, Biostatistics, or related field with 3+ years industry experience.
* MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
* 1+ years with regulatory submissions
* Successful publication experience.
* 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.
** Desired

Experience:

*** 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 Neuroscience therapeutic area.
* Experience with CDISC, including SDTM, ADaM, CDASH.
* Experience with Multiple imputations.
* Knowledge of simulations, multivariate analyses, and biomarker analyses**#LI-Remote****#LI-NITINMAHAJAN
** IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create…