Principal Biostatistician FSP Early Phase
Principal Biostatistician FSP Early Phase
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$ 122800 - 233400
1 Vacancy
Job Description
Job Level: FSP Principal Biostatistician (FSP) for Early Phase
Location: Homebased 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 to market.
Job Summary:
The Principal Biostatistician is responsible for providing statistical support for drug development programs in early phases.
Additional Benefits:
- Homebased remote working opportunities
- Work/life balance as well as flexible schedules
- Collaborating with motivated highperformance statistical and research teams
- Technical training and tailored development curriculum
- Research opportunities that match your unique skillset
- Promising career trajectory
- Job stability: longterm engagements and redeployment opportunities
- Focus on bringing new therapies to market rather than project budgets and change orders.
- Experience with regulatory submissions.
- Engaging fastpaced environment.
- Good worklife balance.
Job Requirements:
- Collaborate with 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 with statistical expertise.
- 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 preIND and NDA activities.
- Participates in other activities and meetings to support Biostatistics and the Development Team as needed.
Qualifications (Minimal acceptable level of education work experience and competency)
- 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.
- Early Phase Oncology experience is PREFERRED.
- Experience to help with dose escalation studies efficacy endpoints and solid tumor.
- 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.
- Understanding of ICH GCP as well as general knowledge of industry practices and standards.
- Experience with CDISC including SDTM Adam CDASH
Desired Experience:
- Familiarity with R programming language and other statistical software including EAST.
- Experience with Bayesian methods
- Knowledge of simulations multivariate analyses and biomarker analyses
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IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $122800.00 $233400.00. The actual base pay offered may vary based on a number of factors including jobrelated qualifications such as knowledge skills education and experience; location; and/or schedule (full or parttime). 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.
Required Experience:
Staff IC
Employment Type
Full-Time
