Senior Biostatistics Manager, Biosimilars

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🕒 vor 1 Monat

🏛️ District of Columbia, Washington – Remote

🏛️ District of Columbia – Remote ☕ Washington – Remote

⏰ Vollzeit

🟠 Senior

👔 Manager

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Lifelancer

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2020

💼 Beratung

🏥 Gesundheitswesen

📦 Logistik

💰 Pre Seed Round im 2022-03

Consulting • Healthcare • Logistics

Lifelancer ist eine KI-gestützte Talentvermittlungsplattform, die Arbeitgeber mit qualifizierten Fachleuten im Bereich Life Sciences, Pharmazie und IT verbindet. Die Plattform ermöglicht es Einzelpersonen, Profile zu erstellen, die ihre Fähigkeiten zeigen, mit gut bezahlten internationalen Jobs oder Projekten zusammenzubringen, und erleichtert Arbeitgebern die Einstellung und Gehaltsabrechnung in mehreren Ländern. Die Plattform zielt darauf ab, den Einstellungsprozess durch effizientes KI-Sourcing und Unterstützung bei der Einhaltung von Vorschriften zu optimieren.

Beschreibung

• Lead a single large product, and/or more complex studies and/or projects • Ensure that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct • Influence and contribute to the development strategy, and defend statistical approaches internally and externally • Implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis • Plan and execute statistical contributions to protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), and other communications in close partnership with CROs in a full-service CRO model • Provide statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents • Oversee statistical work performed by CROs in a full-service CRO model • Perform statistical analysis of multiple studies/projects and subsequent exploratory analyses, and make sound conclusions and recommendations • Represent the Biostatistics function and participate in multidisciplinary project team meetings; collaborate closely with other functional team members; incorporate knowledge of cross-functional areas to inform and provide sound statistical guidance to teams (e.g. provide support and input in case report form design, and data collection) • Proactively anticipate and communicate resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally • Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines and industry practice on biosimilar development • Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances by publishing applied research in scientific journals and books and presenting statistical methodology at internal or external scientific meetings • Participate in the review of CRO Policies, SOPs and other controlled document development, and in the development and review of Amgen-CRO’s process maps; contribute to process improvement and operational efficiency • Adhere to all Amgen Policies, Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development

🎯 Anforderungen

• Doctorate degree and 2 years of Biostatistics experience OR Master’s degree and 6 years of Biostatistics experience OR Bachelor’s degree and 8 years of Biostatistics experience • Masters degree in Statistics/Biostatistics or other subject with high statistical content, and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research • Knowledge/experience of biosimilars development, non-inferiority or equivalence trials • Statistical contributions to regulatory submissions • Experience in statistical methodologies related to adaptive designs (e.g., group sequential design, adaptations to treatment arm selection design, Bayesian adaptive design) and/or combined phase 1/2 or phase 2/3 design • Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia • Demonstrated ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements • Demonstrated ability in presenting results and defending statistical findings, study design and analysis. This could be to internal audiences (study/product team) or at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings • Demonstrated ability in working within a global team and with CRO partners to ensure operational excellence and efficiencies • Demonstrated effective communication skills (written and oral)

🏖️ Vorteile

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and vision coverage • life and disability insurance • flexible spending accounts • A discretionary annual bonus program • stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible