Principal Biostatistician FSP RWE
Principal Biostatistician FSP RWE
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$ 131300 - 243900
1 Vacancy
Job Description
Job Level: FSP Principal Biostatistician for RWE Research
Location: Homebased in the U.S. or Canada
Why DSSS
Data Sciences Staffing Solutions DSSS 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 collaborating with exert sponsor teams. 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 full range statistical support for drug development based on real world evidence (RWE).
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 goals and timelines.
- Serves as statistical lead and represents Biometrics on health outcomes and epidemiology studies.
- Serves as subject matter expert for RWE/HEOR/HTA research design methodologies data sources analytic techniques and reporting.
- Writes statistical analysis plans.
- Provides strategic and tactical support for crossfunctional RWE development for regulators payers and clinicians.
- Leverages administrative claims electronic medical records registries or other realworld data and recommends optimal study designs.
- Selects and implements appropriate analytical methods including statistical models or machine learning models to align with overall business objectives.
- Develops high quality study protocols statistical analysis plans study reports and other study documents.
- Identifies innovation opportunities for the use of RWD.
- Establishes effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWD.
- Commitment to maintaining the highest standards of data accuracy and integrity by implementing rigorous quality control processes throughout the data handling and analysis phases.
- Demonstrated ability to quickly adapt to new requirements and efficiently handle adhoc requests.
Required Knowledge Skills and abilities:
- Indepth knowledge of RWE databases including large administrative claims data EMR disease registries and clinical trial data.
- Demonstrated ability in evaluation and development of RWE from conceptualization through application.
- Ability to execute statistical analysis plans using advanced programming techniques to perform detailed and complex analyses relevant to realworld evidence.
- Ability to effectively interpret and communicate research results to internal and external audiences.
- Understanding of ICH GCP and E9 as well as general knowledge of industry practices and standard
- Knowledge of global regulatory and HTA requirements for RWE
Required Education and Experience: (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.
- Experience leading secondary data analysis including medical claims electronic medical records chart reviews and registries.
- Excellent organizational skills and proven ability to effectively lead multiple projects to successful completion.
- SMElevel proficiency in SAS programming tailored to handle complex inclusion and exclusion criteria conduct propensity score matching and develop outcome metrics.
- Expertise in R is also valued.
- Experience with CDISC ADAM datasets.
- Extensive working experience with stakeholders such as medical affairs and health economics
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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 $131300.00 $243900.00. 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
