Job Level: FSP Principal Biostatistician for Early Phase Clinical Development (PK)

Location: Home-based in the U.S. or Canada

Why DSSS?

Data Sciences Staffing Solutions, 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 collaborating with sponsor teams 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 of development, focusing on healthy normal studies with PK and PD endpoints.

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 multidisciplinary project teams to establish project timelines.
• Provide statistical input to study synopses and protocols.
• Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.
• Write or review statistical analysis plans, dataset and TLF specifications.

• 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.
• Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
• Collaborates with Data Management, Clinical Development, and Clinical Pharmacologists with statistical expertise.
• Contributes to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, etc.
• Support exploratory analyses and publications.
• Participate in pre-IND and NDA activities.
• Participates in other activities and meetings to support Biostatistics and the Development Team as needed.
• Demonstrated ability to work independently in project management and decision making.
• Able to effectively communicate statistical concepts to colleagues.
• Able to effectively manage CROs.
• Use SAS and/or R to perform inferential analyses and validate important data derivations when necessary.

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.
• 3+ years of experience in statistical analysis of PK and PD endpoints in pharmaceutical industry
• 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.
• 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 https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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.