FSP Principal Biostatistician, Medical Affairs
$111k - $309kIQVIA
IQVIA seeks a Principal Biostatistician to provide statistical analysis support for Phase 2 and 3 clinical trials through an embedded partnership model. The role involves collaborating with cross-functional sponsor teams on study design, analysis planning, and regulatory submissions.
Responsibilities
- Establish project objectives and timelines with multi-disciplinary teams
- Author statistical analysis plans and interpret study results
- Program or validate statistical outputs and review reports for accuracy
- Support exploratory analyses and contribute to publications and presentations
- Provide guidance to statistical programmers on analysis planning and execution
Requirements
- PhD in Statistics, Biostatistics, or related field with 5+ years industry experience, OR MS with 7+ years experience
- Minimum 3 years Phase 2/3 clinical trial experience
- Proficiency in SAS or R for efficacy, safety analyses, and data validation
- Knowledge of ICH GCP, ICH E9, and industry standards
- Experience with CDISC standards including SDTM, ADAM, CDASH
- Ability to work independently in fast-paced environment and manage programmers effectively
- Strong written and verbal communication skills
Compensation: $111,000–$309,000 base
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the FSP Principal Biostatistician, Medical Affairs in Durham, NC vacancy
$111k - $309k
Job Level: FSP Principal Biostatistician for RWE ResearchLocation: Home-based in the U.S. or CanadaWhy DSSS... ...administrative claims, electronic medical records, registries, or other real-world... ...with stakeholders such as medical affairs and health economicsPreferred but not...PrincipalMedicalFull timePart timeWork experience placementImmediate startRemote workWork from homeWorldwideFlexible hoursIQVIA
Durham, NC4 days ago$111k - $309k
...IQVIA seeks a Principal Biostatistician to provide statistical analysis support for Phase 2 and 3 clinical trials through an embedded partnership model. The role involves collaborating with cross-functional sponsor teams on study design, analysis planning, and regulatory...PrincipalMedicalIQVIA
Durham, NC1 day ago- ...Principal Biostatistician providing statistical leadership for real-world evidence research within a functional service provider model at IQVIA. Role involves designing RWE studies, developing analytical strategies, and supporting regulatory and payer submissions across...Principal
IQVIA
Durham, NC6 days ago $96.4k - $241k
...exciting journey!**The Global Biostatistics (Data Sciences, Safety & Medical) team at IQVIA are experienced in submissions for all major... ...; working together with key groups such as, Global Regulatory Affairs, Safety, Project and Data Management, and Medical Writing, to...MedicalFull timePart timeImmediate startWork from homeWorldwideIQVIA
Durham, NC5 days ago$109.2k - $273k
Join IQVIA’s Sponsor-Dedicated FSP team and help advance healthcare through real-world... ...Clinical Development, Safety, Regulatory Affairs, Biostatistics, and Real-World Evidence stakeholders... ...and commercialization of innovative medical treatments to help improve patient...MedicalFull timePart timeImmediate startRemote workWorldwideIQVIA
Durham, NC3 days ago$96.4k - $309k
...Principal Biostatistician role supporting pharmaceutical clinical trials through study design, power calculations, and statistical analysis. Position involves collaborating with cross-functional teams on regulatory submissions and clinical development activities, based...PrincipalRemote work- ...health and improving lives.Labcorp is seeking a Senior Lead Biostatistician - Oncology Evidence Generation to join our team in Raleigh/Durham... ...per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO)...MedicalTemporary workCasual workMonday to FridayFlexible hours
Laboratory Corporation of America
Durham, NC6 days ago $101.97k - $164.76k
...collaborative and analytically driven Biostatistician III to join our research team. In this... ...Provide statistical consultation to principal investigators, faculty researchers, research... ...provides comprehensive and competitive medical and dental care programs, generous...MedicalTemporary workWork experience placementRemote workDuke University
Durham, NC2 days ago$84.4k - $211.1k
...Overview We are seeking an experienced Principal Medical Writer to lead the development of high-quality clinical and regulatory documents supporting... ...with cross-functional stakeholders (Clinical, Regulatory Affairs, Biostatistics, Safety, etc.) to gather, interpret, and...PrincipalMedicalFull timePart timeImmediate startWorldwideIQVIA
Durham, NC2 days ago$272k - $431.25k
...the GPU - the engine of modern visual computing - the field has expanded to encompass video games, movie production, product design, medical diagnosis and scientific research. Today, we stand at the beginning of the next era, the AI computing era, ignited by a new...PrincipalMedicalFull timeNvidia
Durham, NC5 days ago- ...Principal Medical Writer ViiV Healthcare, a global specialty HIV company, is seeking a Principal Medical Writer who will lead and deliver high-quality medical writing for complex clinical and regulatory projects. You will work closely with clinical, regulatory, statistical...PrincipalMedicalLocal areaRemote work
ViiV Healthcare
Durham, NC4 days ago $137.2k
The Insights and Analytics Principal is a senior analytics leader responsible for driving business growth, shaping analytic solutions, and... ...accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population...PrincipalMedicalFull timePart timeImmediate startWorldwideIQVIA
Durham, NC2 days ago- ...Principal Investigator Durham, NC IMA Clinical Research | New Site Launch IMA Clinical Research is expanding into Durham, NC and... ...IIIV; we do not conduct Phase I studies) Conduct study-related medical evaluations and procedures in accordance with approved protocols...PrincipalMedicalFull timePart timeLocal areaFlexible hours
$100k - $145k
...join us.OverviewCypress Creek Energy is seeking an Environmental Affairs team member to support development of transmission-and... ...observed holidays.401(k) MatchComprehensive package including medical, dental, vision and health insuranceWellness stipend, family planning...MedicalWork at officeLocal areaRemote work3 days per weekCypress Creek Renewables
Durham, NC4 days ago$260k - $300k
...accelerated intelligence. Learn about the Danaher Business System which makes everything possible.The Senior Director, Medical & Scientific Affairs - Specialty Testing is responsible for setting the vision and strategic direction for the Specialty Testing business area...MedicalFull timeRemote workWork from homeFlexible hoursDanaher Corporation
Durham, NC2 days ago$111k - $309.2k
...is incorporated into the development and commercialization of medication and other drug/non-drug interventions. We focus on understanding... ...development and growth.Role & ResponsibilitiesAs an Associate Principal within the PCS CNS Practice at IQVIA, you will be responsible...PrincipalMedicalFull timePart timeImmediate startWorldwideIQVIA
Durham, NC5 days ago- ...the world. Together, we’re improving health and improving lives.Principal Reliability EngineerBurlington, NC, Indianapolis IN or Durham,... ...hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or...PrincipalMedicalTemporary workFor contractorsCasual workInternshipFlexible hours
Laboratory Corporation of America
Durham, NC3 days ago - ...The Principal Statistical Programmer will lead programming activities for one or more studies, ensuring high-quality development, validation... ...origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under...PrincipalMedicalLocal areaWorldwide
ViiV Healthcare
Durham, NC4 days ago $89.9k - $250.4k
...contract development Maintain competitive knowledge of FSP offerings and position versus competitors Support... ...in data management, biostatistics, programming, medical writing, safety, or regulatory affairs preferred ~ Excellent presentation and writing skills...MedicalContract workIQVIA
Durham, NC9 days ago- ...Healthcare domain experience, particularly with laboratory systems, medical devices, or clinical workflows.Experience with Terraform for... ...customer-facing activities (e.g., implementation, audits).The Principal Software Engineer is one of the highest-level individual...PrincipalMedicalFull timeTemporary workCasual workInternshipMonday to FridayFlexible hoursDay shift
Laboratory Corporation of America
Durham, NC4 days ago $125.8k - $350.3k
...Location Remote, must be based in US. Overview Associate Principals are methodologic experts with substantial experience in... ...accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health...PrincipalMedicalFull timePart timeImmediate startRemote workWorldwide- ...onsite / 5 days in either Durham, NC Our client seeks a Principal Systems Analyst to serve as the liaison among business, product... ...2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life...PrincipalMedicalHourly payTemporary workLocal area
Eliassen Group
Durham, NC2 days ago $135k - $150k
...Fortrea seeks a Senior Clinical Scientist in immunology to lead Phase 1-3 clinical trials and oversee medical monitoring activities. This clinical development role requires managing study design, coordinating safety committees, and serving as the scientific point of contact...MedicalFortrea
Durham, NC9 days ago$167.9k
...Principal Engineer Analog Design #WeAreIn for jobs that impact everyone's life. What if your ideas could change the way the world... ..., religion, sex (including pregnancy, childbirth, or related medical conditions), gender identity, national origin, ancestry, citizenship...PrincipalMedicalLocal areaInfineon Technologies
Morrisville, NC2 days ago$192.2k - $264.3k
...change the way the world connects, powers up, or thinks? As a Leas Principal Engineer Analog Design on our Research & Development team, you'... ..., religion, sex (including pregnancy, childbirth, or related medical conditions), gender identity, national origin, ancestry,...PrincipalMedicalLocal areaInfineon Technologies
Morrisville, NC2 days ago$89.9k - $250.4k
...Associate Director, Data Sciences, Safety, and Regulatory FSP Sales To be eligible for this position, you must... ...the Data Management, Biostatistics, Programming, Medical Writing, Lifecycle Safety, and Regulatory Affairs functions - and will be responsible for achieving...MedicalFull timeContract workPart timeBank staffImmediate startWorldwide- ...Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an Bioinformatics Scientist to support the National Institutes of Health (NIH) in...MedicalLong term contractFull time
Kelly
Durham, NC3 days ago - ...applications like artificial intelligence, high performance computing, satellite communications, radar, unmanned aerial vehicles, medical equipment, test and measurement and advanced wireless networks.MACOM has more than 75 years of expertise in semiconductor process development...PrincipalMedicalPermanent employmentWork at office
MACOM
Morrisville, NC2 days ago - ...computing, satellite communications, radar, unmanned aerial vehicles, medical equipment, test and measurement and advanced wireless networks.... ...Engineer - PrincipalPosition Summary MACOM is seeking a Principal Applications Engineer to serve as a senior technical leader for...PrincipalMedicalPermanent employmentImmediate start
MACOM
Morrisville, NC6 days ago $140.2k - $390.6k
...Job Overview The Medical Evidence Development Asset Lead FSP within the Chief Medical Office organization will oversee Asset-Level Evidence Generation... ...Engage with all relevant stakeholders (e.g., Medical Affairs, Epidemiology/RWE, Statistics/Programming, Regulatory,...MedicalFull timeTemporary workPart timeWork at officeImmediate startWorldwideShift workIQVIA
Durham, NC27 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to FSP Principal Biostatistician, Medical Affairs. Be the first to apply!
Related searches