Principal Biostatistician FSP, Early Phase

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

Job summary

An established industry player is seeking a Principal Biostatistician to drive statistical support for early-phase drug development. In this role, you will collaborate with multi-disciplinary teams, contribute to clinical trial protocols, and provide statistical analysis plans. You will also have the opportunity to influence the future of medicine by working closely with top pharmaceutical and biotech companies. This position offers a unique chance to work in a home-based environment while impacting critical research and development efforts. If you are passionate about biostatistics and eager to make a difference, this role is perfect for you.

Qualifications

• PhD or MS in Statistics/Biostatistics with relevant industry experience.
• Proficient in SAS and R for statistical analyses.

Responsibilities

• Provide statistical support for drug development in early phases.
• Collaborate with project teams to establish timelines and protocols.

Skills

Statistical Analysis

Project Management

Communication Skills

Independent Decision Making

SAS Programming

R Programming

Clinical Trial Protocols

Regulatory Submissions

Education

PhD in Statistics or Biostatistics

MS in Statistics or Biostatistics

Tools

SAS

R

EAST

CDISC Standards

Job description

Job Level: FSP Principal Biostatistician (FSP) for Early Phase

Location: Home-based 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.

Job Requirements:

1. Collaborate with multi-disciplinary project teams to establish project timelines.
2. Provide statistical input to study protocols.
3. Write the statistical sections of clinical trial protocols, while consulting with internal and external experts.
4. Write statistical analysis plans.
5. Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
6. Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
7. Contribute to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, etc.
8. Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures.
9. Interpret study results and review reports of study results for accuracy.
10. Participate and contribute to authoring of Clinical Development Plan.
11. Support exploratory analyses and medical affairs publications.
12. Participate in pre-IND and NDA activities.
13. Participate in other activities and meetings to support Biostatistics and the Development Team as needed.

Qualifications (Minimal acceptable level of education, work experience, and competency)

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. Early Phase Oncology experience is PREFERRED.
4. Experience to help with dose escalation studies, efficacy endpoints and solid tumor.
5. 1+ years with regulatory submissions.
6. Successful publication experience.
7. Demonstrate ability to work independently in project management and decision making.
8. Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
9. Ability to use SAS and/or R to perform efficacy analyses and validate important data derivations when necessary.
10. Understanding of ICH GCP as well as general knowledge of industry practices and standards.
11. Experience with CDISC, including SDTM, Adam, CDASH.

Desired Experience:

1. Familiarity with R programming language and other statistical software, including EAST.
2. Experience with Bayesian methods.
3. Knowledge of simulations, multivariate analyses, and biomarker analyses.

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