[Remote] FSP reputed company Biostatistician, Safety Analytics

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. 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 reputed company development of safety deliverables, including specialty areas such as Hypersensitivity, Injection/Infusion Site Reaction • Support Safety Analytics and the study team on the delivery of Patient Profile display for Hepatic or other areas • 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 reputed company 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 reputed company-IND or NDA activities Skills • PhD in Statistics, Biostatistics, or reputed company field with 3+ years industry experience • MS in Statistics, Biostatistics, or reputed company 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 (reputed company and customized reputed company review) • Ability to follow data specifications and programming specifications and reputed company reputed company, 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 reputed company cause and errors • Strong communication and time management: reputed company realistic reputed company estimates, flag risks/delays early, and ask the right questions to reputed company 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 SDTM and CDASH • Leading DSBM or DMC for biostatistics Benefits • Home-based remote working opportunities. • Work/life balance as reputed company as flexible schedules. • 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. • reputed company 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. reputed company • reputed company provides analytics, compliance, and reputed company to the life sciences industry. It was founded in 1982, and is headquartered in Danbury, Connecticut, USA, with a workforce of 10001+ employees. Its website is https://www.reputed company.com. Company H1B Sponsorship • reputed company has a reputed company record of offering H1B sponsorships, with 74 in 2026, 166 in 2025, 286 in 2024, 257 in 2023, 229 in 2022, 208 in 2021, 180 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply To this Job