Biostatisticien Senior FSP, Phase Tardive (Senior Biostatistician)

Biostatisticien Senior FSP, Phase Tardive (Senior Biostatistician)

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 Senior Biostatistician is responsible for providing statistical support for drug development programs in phases 2 or 3 with efficacy and safety 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.
• Write or review 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.
• Effectively manage internal and CRO project activities including timelines, deliverables, and availability of resources.
• Collaborate with Data Management, Statistical Programming and Clinical Development, with statistical expertise.
• Use SAS and/or R to perform inferential analyses and validate important data derivations.
• Support exploratory analyses and publications.
• Contribute to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, Benefit-Risk analyses, IB, etc.
• Participate in NDA and related activities.
• Participate in activities and meetings to support Biostatistics and the Development Team.
• Demonstrated ability in working independently, project management and decision making.
• Able to effectively communicate statistical concepts.
• Compliance with SOPs and best practices to ensure quality work product.

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

• PhD in Statistics, Biostatistics, or related field with 3+ years industry experience.
• MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• Understanding of ICH and FDA Guidance 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
• Experience in a range of therapeutic areas
• Production programming of statistical outputs
• Regulatory submission activities
• Estimand framework

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