Responsible for developing and overseeing statistical programming deliverables, including SDTMs, ADaMs, and TLFs for clinical studies. Ensures all programming processes align with regulatory requirements and collaborates with statisticians and CROs to meet study goals.
SERVIER MONDE
13 Remote Job Openings at SERVIER MONDE
Lead the statistical strategy for clinical development products and evidence generation while supervising in-house and CRO statisticians. Act as the primary biostatistics expert for cross-functional teams and represent the company in interactions with regulatory authorities.
Direct the execution of statistical analyses and provide scientific validity for clinical development plans and regulatory submissions. Partner with cross-functional stakeholders to integrate statistical perspectives into data packages and regulatory meetings.
The role is responsible for driving sales performance and managing accounts for oncology products indicated for Acute Lymphoblastic and Myeloid Leukemia. It involves developing territory business plans and maintaining strong relationships with healthcare customers and co-promotion partners.
Lead statistical programming activities for multiple studies or assets, ensuring deliverables align with regulatory requirements and internal procedures. Manage study leads and vendors while overseeing the development of analysis datasets and outputs.
Director, Contracting Strategy & Administration
SERVIER MONDE
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Full Time
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a month ago
SERVIER MONDE
Lead the design, financial modeling, and lifecycle management of commercial and payer value propositions to optimize patient access and GTN performance. Bridge the gap between high-level value strategy and operational execution across government pricing and rebate administration.
Lead the operational integrity of commercial and government contracting, including the calculation and submission of mandated pricing metrics like AMP and Best Price. Oversee rebate adjudication processes and manage the Contract Management System to ensure compliant reporting and execution.
Executive Director, U.S. Pricing & Contracting
SERVIER MONDE
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Full Time
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a month ago
SERVIER MONDE
Lead the strategic and operational execution of U.S. commercial pricing and contracting to maximize patient access and net revenue. Manage government price reporting, GTN accruals, and chair the U.S. Organizational Pricing Committee.
Sr Mgr, US Forecasting & Integrated Insights (Oncology)
SERVIER MONDE
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Full Time
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a month ago
SERVIER MONDE
Lead the development of data-driven forecasts for the US Oncology portfolio and synthesize diverse data streams into a cohesive brand narrative. Collaborate cross-functionally to align clinical assumptions and market dynamics to drive strategic decision-making.
Director, Contract Administration & Government Pricing
SERVIER MONDE
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Full Time
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a month ago
SERVIER MONDE
Lead the operational integrity of commercial and government contracting, including the calculation and submission of mandated pricing metrics. Oversee rebate adjudication processes and manage the Contract Management System to ensure regulatory compliance.
Serve as the technical subject matter expert for outsourced drug-substance manufacturing, overseeing technology transfers, validations, and lifecycle management of complex biologics. Lead technical interfaces with global CMOs and author CMC sections for global regulatory submissions.
Drive sales performance and achieve targets for solid tumor disease states, specifically Low Grade Glioma and Cholangiocarcinoma, within the Northwest territory. Develop strategic account plans and maintain strong professional relationships with healthcare customers and co-promotion partners.
Lead US regulatory strategy and FDA engagement for assigned projects, focusing on expedited pathways and submission strategies for INDs, NDAs, and BLAs. Collaborate with the Global Regulatory Team to align US development plans with global goals and provide subject matter expertise on FDA guidance.
