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Job Title: Director, Biostatistics (Oncology Indication Lead) Full time permanent - Direct with a global pharmaceutical company Location: Basking Ridge, NJ - this can be fully remote but need to be onsite once every 3 months, and or very important meetings Must be US Based in EST or CST time zones Prior experience as a Statistician indication lead for an Oncology trial is needed.
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Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan.
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Global BDO Strategy to Improve Drug Development: Leads global BDO initiatives to improve the harmonization and efficiency of drug development which leads to cost savings with minimal supervision.
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BDO is seeking a Managing Director to lead the National Security & Critical Infrastructure Protection (NS-CIP) Practice. The NS-CIP Practice focuses on advancing the mission of national security and critical infrastructure protection by tackling key challenges, such as warfighter defense innovation challenges, threat modeling, smart grid data protection, border and pipeline security transformation, Committee on Foreign Investments (CFIUS) compliance, and meeting defense security standards and Cybersecurity and Infrastructure Security Agency (CISA) obligations.
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Lead UStoy launch strategy for WoW brands with 5-year outlook, presented to Marketing leadership team to guide future BDO development, outlining white-space opportunities to chase. Deliver annual BDO for portfolio in partnership with design lead and category leadership, presented to the Sr. Leadership Team. Beginning with the financial planning process, identify growth opportunities, across owned IP and Licensed brands, within white space product/category opportunities to guide marketing and development teams.
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As an independent member of the BDO Alliance, we have access to the resources of BDO USA, LLP, the world's 5th largest accounting and consulting firm. As a tax manager, you will lead and manage all phases of non-profit and individual client tax advisory and compliance engagements.
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Director, Biostatistics (Indication Lead) page is loaded. Director, Biostatistics (Indication Lead) Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document (eCTD.
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May participate in meeting or teleconferences with Health Authorities Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
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About the team : As the Mobility Aftermarket (MA) Business Digital Organization (MA/BDO) we lead, support and assist our MA business partners in developing, transforming or initiating digital offerings for our customers.
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Global BDO Strategy: Drive initiatives to enhance the harmonization and efficiency of drug development on a global scale, contributing to cost savings. Lead the planning, analysis, and interpretation of integrated efficacy and safety data, ensuring consistency and scientific integrity throughout the drug project lifecycle.
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We are seeking a Senior Biostatistician to spearhead intricate studies and entire drug projects with a focus on study design, data analysis, and result interpretation. Drug Development Strategy: Offer strategic input into development plans to ensure alignment with product profiles and regulatory expectations.
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Job Summary:BDO Capital is seeking a top-tier Managing Director to lead and build a Dallas-based investment banking group. Job Summary:BDO Capital is seeking a top-tier Managing Director to lead and build a Dallas-based investment banking group.
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Operating with autonomy and minimal supervision, this role plays a pivotal part in shaping drug development plans, contributing to regulatory responses, and collaborating with global project teams, Health Authorities, and contract research organizations (CROs.
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PhD in Statistics or Biostatistics is preferred. Research statistical methodologies and address specific statistical challenges across all stages of drug development. Global Health Authority Interaction: Prepare and submit documents and responses to Health Authorities globally, representing the statistical function in meetings as necessary.
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Master's Degree in Statistics or Biostatistics is required. Ability to travel up to 20%, including international travel. Provide guidance on innovative study design while ensuring adherence to regulatory requirements across various regions.
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