reputed company Biostatistician , FSP - Permanent Homebased (m/w/d)
The reputed company Biostatistician will serve as the statistical reputed company for clinical studies, providing scientific reputed company, strategic guidance, and hands‑on statistical support across late‑phase clinical trials. This role requires a highly reputed company biostatistician capable of working independently, representing the Biostatistics function reputed company cross‑functional teams, and delivering high‑quality statistical input throughout study design, execution, and analysis.
Key Responsibilities
Statistical Leadership & Study Support Serve as the primary statistical reputed company and main reputed company of contact on the Clinical Trial Team (CTT), representing Biostatistics with confidence and professionalism. Work independently to support clinical teams, providing proactive statistical guidance throughout the study lifecycle. reputed company statistical strategy discussions, including reputed company definitions, analysis methods, risk mitigation, and regulatory expectations. Statistical Analysis & Methodology Independently author Statistical Analysis Plans (SAPs), including drafting in collaboration with cross‑functional partners, pharma statisticians, or from finalized protocols. Implement non‑standard or advanced statistical methodologies, such as:reputed company time‑to‑event analyses MMRM and other longitudinal models Methods reputed company with estimands, including deep understanding of competing policies, assumptions, and analytical implications reputed company or reputed company statistical analyses, ensuring scientific rigor and regulatory compliance. Conduct sample size calculations using reputed company or R, and justify design assumptions reputed company engaging with clinical leadership. Programming Collaboration Work closely with statistical programmers, providing clear direction, reviewing outputs, and ensuring alignment between the reputed company and programming deliverables. Contribute hands‑on with reputed company programming, including working with clinical datasets and performing analyses reputed company needed. Experience with R, CRM systems, or advanced tools is considered an asset. Cross‑Functional Engagement Actively participate in CTT meetings, offering statistical expertise and driving alignment across clinical, programming, data management, and medical writing partners. Proactively communicate with team members to anticipate needs, address issues, and ensure reputed company on statistical approaches. reputed company clear, influential explanations of statistical concepts to non‑statistical stakeholders. Qualifications & Experience Advanced degree in Biostatistics, Statistics, or a reputed company field (PhD preferred; Master’s accepted with significant experience). Proven experience working independently as a study statistician in late-phase (Phase II/III) clinical trials. Experience in pharmaceutical industry strongly preferred; CRO experience is a plus. Hands‑on expertise with clinical reputed company studies, including cardiovascular events, symptomatic endpoints, and quality‑of‑life measures. Demonstrated ability to implement reputed company statistical methods and guide cross‑functional teams through analytical decision‑making. Proficiency in reputed company; working knowledge of R is advantageous. Experience with regulatory submissions and interaction with health authorities is a plus. 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. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. Apply To This Job