Principal Biostatistician, FSP, Late Phase

IQVIA; Durham (NC); Remote; USD 131,000 - 244,000; Full time

Job summary

An established industry player seeks a Principal Biostatistician to provide statistical support for clinical trials. This role offers the opportunity to work with top pharmaceutical and biotech companies, influencing the future of medicine. You'll collaborate with high-performance teams, engage in technical training, and enjoy a promising career trajectory. The position emphasizes work-life balance and flexibility, allowing you to focus on advancing therapies to market. If you have a strong background in statistics and a passion for research, this role is perfect for you.

Benefits

Home-based remote working opportunities

Flexible schedules

Technical training

Long-term engagements

Good work-life balance

Qualifications

• 5+ years of industry experience in statistical support for clinical trials.
• Ability to communicate effectively and manage teams.

Responsibilities

• Collaborate with project teams to establish objectives and timelines.
• Write statistical sections of clinical trial protocols.

Skills

Statistical Analysis

Communication Skills

Project Management

R or SAS Programming

Clinical Trial Experience

Education

PhD in Statistics or Biostatistics

MS in Statistics or Biostatistics

Tools

R

SAS

CDISC Standards

Job description

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Job Level: FSP Principal Biostatistician, Late Phase

Job Level: FSP Principal Biostatistician, Late Phase

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 yields all the benefits of working for an industry leading global CRO and collaborating directly with cross-functional sponsor teams. 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 pharmaceutical clinical trials in patients.

Additional Benefits:

• Home-based remote working opportunities.
• Work/life balance as well as flexible schedules.
• Collaborating with motivated, high-performance, statistical and research teams.
• Technical training and tailored development curriculum.
• Research opportunities that match your unique skillset.
• Promising career trajectory.
• Job stability: long-term engagements and re-deployment opportunities.
• Focus on bringing new therapies to market rather than project budgets and change orders.
• Experience with regulatory submissions.
• Engaging, fast-paced environment.
• Good work-life balance.
  
  

Job Responsibilities:

• Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
• Write the statistical sections of clinical trial protocols, while consulting with internal and external experts.
• Author statistical analysis plans.
• Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
• Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
• Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc.
• Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming/validation of tables, listings, and figures.
• Perform validation of analysis variables and statistical outputs
• Interpret study results and review reports of study results for accuracy.
• Support exploratory analyses.
• Participate in pre-IND or 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.
• At least 3 years in Phase 2/3 clinical trial experience.
• Demonstrated ability to work pro-actively and independently.
• Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
• Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary.
• Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
• Experience with CDISC, including SDTM, ADAM, CDASH
  
  

Desired Experience:

• Multiple imputation methods
  
  

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 https://jobs.iqvia.com

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. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $131,300.00 - $243,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). 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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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