Principal Biostatistician FSP, RWE

IQVIA; Durham (NC); Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Principal Biostatistician to provide comprehensive statistical support for drug development based on real-world evidence. In this pivotal role, you will collaborate with multi-disciplinary teams, serve as a statistical lead, and leverage various data sources to influence the future of medicine. This position offers the unique opportunity to work with world-class pharmaceutical and biotech companies, ensuring the highest standards of data accuracy and integrity. If you are passionate about advancing therapies and have a strong background in statistics and RWE, this is the perfect opportunity for you.

Qualifications

• 5+ years of experience in drug development and real-world evidence.
• Expertise in statistical analysis plans and advanced programming techniques.

Responsibilities

• Lead statistical support for drug development based on real-world evidence.
• Collaborate with project teams to establish goals and timelines.

Skills

Statistical Analysis

Real World Evidence (RWE)

SAS Programming

R Programming

Data Analysis

Communication Skills

Education

PhD in Statistics or Biostatistics

MS in Statistics or Biostatistics

Tools

SAS

R

CDISC ADAM

Job description

Job Level: FSP Principal Biostatistician for RWE Research

Location: Home-based 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 expert 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).

Job Requirements:

1. Collaborate with multi-disciplinary project teams to establish project goals and timelines.
2. Serves as statistical lead and represents Biometrics on health outcomes and epidemiology studies.
3. Serves as subject matter expert for RWE/HEOR/HTA research design, methodologies, data sources, analytic techniques, and reporting.
4. Writes statistical analysis plans.
5. Provides strategic and tactical support for cross-functional RWE development for regulators, payers, and clinicians.
6. Leverages administrative claims, electronic medical records, registries, or other real-world data and recommends optimal study designs.
7. Selects and implements appropriate analytical methods including statistical models or machine learning models to align with overall business objectives.
8. Develops high quality study protocols, statistical analysis plans, study reports, and other study documents.
9. Identifies innovation opportunities for the use of RWD.
10. Establishes effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWD.
11. Commitment to maintaining the highest standards of data accuracy and integrity by implementing rigorous quality control processes throughout the data handling and analysis phases.
12. Demonstrated ability to quickly adapt to new requirements and efficiently handle ad-hoc requests.

Required Knowledge, Skills, and abilities:

1. In-depth knowledge of RWE databases, including large administrative claims data, EMR, disease registries, and clinical trial data.
2. Demonstrated ability in evaluation and development of RWE from conceptualization through application.
3. Ability to execute statistical analysis plans using advanced programming techniques to perform detailed and complex analyses relevant to real-world evidence.
4. Ability to effectively interpret and communicate research results to internal and external audiences.
5. Understanding of ICH GCP and E9 as well as general knowledge of industry practices and standards.
6. Knowledge of global regulatory and HTA requirements for RWE.

Required Education and Experience:

1. PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
2. MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
3. Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries.
4. Excellent organizational skills and proven ability to effectively lead multiple projects to successful completion.
5. SME-level proficiency in SAS programming tailored to handle complex inclusion and exclusion criteria, conduct propensity score matching, and develop outcome metrics.
6. Expertise in R is also valued.
7. Experience with CDISC ADAM datasets.
8. Extensive working experience with stakeholders such as medical affairs and health economics.

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