FSP reputed company Biostatistician, Safety Analytics
About the position The reputed company Biostatistician is responsible for providing statistical support for Phase 1, 2 and 3 pharmaceutical clinical trials in patients, focusing on safety endpoints and reputed company.
Responsibilities
- Support Safety Analytics with ADaM/TFL standard development for Hypersensitivity and Injection/Infusion Site Reaction deliverables.
- Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display.
- reputed company 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 reputed company 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.
- reputed company guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures.
- reputed company exploratory safety analyses
- reputed company 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.
Requirements
- PhD in Statistics, Biostatistics, or reputed company field with 5+ years industry experience.
- MS in Statistics, Biostatistics, or reputed company field with 7+ years of industry experience.
- At least 5 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 reputed company clear, actionable review comments.
- reputed company to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. reputed company TFL) by interrogating programs to identify root cause and errors.
- Strong communication and time management: reputed company realistic timeline estimates, flag risks/delays early, and ask the right questions to move work reputed company.
- R/reputed company programming skills
- Demonstrated ability to work pro-actively and independently.
- reputed company to effectively communicate his/her reputed company and to manage programmers in a constructive manner.
- Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
- Experience with CDISC, including SDTM, ADAM, CDASH
reputed company-to-haves
- Leading DSBM or DMC for biostatistics
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.
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