FSP Principal Biostatistician, Safety Analytics

Job: FSP Principal Biostatistician, Safety Analytics

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 Phase 1, 2 and 3 pharmaceutical clinical trials in patients, focusing on safety endpoints and outcomes.

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:

• Support Safety Analytics with ADaM/TFL standard development for Hypersensitivity, Injection/Infusion Site Reaction or other safety deliverables.
• Support Safety Analytics and the study team on the delivery of Patient Profile display for Hepatic or other areas.
• Provide ADaM/TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries, including cross-checks between interactive outputs and TFLs.
• Interrogating root cause of issues identified during ADaM/TFL/Interactive package review
• Providing statistical leadership and support for safety analyses for Phase 1/2/3 trials.
• Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
• Participating in study design discussions, including protocol development
• Write the statistical sections of clinical trial protocols.
• Reviewing CRFs, data review guidelines, and related study documentation to ensure statistical and safety considerations are appropriately addressed.
• Developing and reviewing statistical analysis plans and TFL templates.
• 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.
• Serving as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements.
• Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures.
• Perform exploratory safety analyses
• Perform validation of analysis variables and statistical outputs
• Interpret study results and review reports of study results for accuracy.
• Present, communicate and interpret safety analyses to study teams
• Support exploratory analyses.
• Participate in pre-IND or NDA activities.

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.
• At least 2 years of Phase 1, 2 and 3 clinical trial experience.
• Strong experience reviewing ADaM datasets and TFLs (standard and customized output review).
• Ability to follow data specifications and programming specifications and provide clear, actionable review comments.
• Able to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. SAS TFL) by interrogating programs to identify root cause and errors.
• Strong communication and time management: provide realistic timeline estimates, flag risks/delays early, and ask the right questions to move work forward.
• R/SAS programming skills
• Demonstrated ability to work pro-actively and independently.
• Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
• Understanding of ICH GCP,