Project-менеджер (remote)

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The Director, Biostatistics provides global Biometrics strategy and leadership in conjunction with the company direction outlined by the Executive Director, Biostatistics. Oversight includes all global operational and financial areas of Biometrics and for any Biometrics model of work (Functional Service Provider (FSP), Full-Service and/or Biometrics Stand Alone). Ensures customer satisfaction with all services and deliverables provided.

Provides support and guidance for the Biometrics department.

Ensures

Biometrics staff comply with Atorus and/or sponsor Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sponsor requirements. full-time remote from anywhere in the EU Job Responsibilities Represents the company in statistical needs and services including the quality control and verification of statistical results; client contact for statistical aspects of clinical studies Develops and maintains department standard operating procedures (SOPs), work instructions (WIs), training, and process documentation Reviews the protocol, case report form (CRF), data management plan, and edit specifications; may write the statistical section of the protocol Develops, reviews, and/or approves randomization specifications and randomization code; requests and performs procedures for breaking the blind Writes and/or reviews statistical analysis plans (SAPs) with table/figure/listing (TFL) shells; this includes SAPs/shells for single studies, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), and interim analyses. Annotates and reviews annotations for TFL shells. Is responsible for the development of automation of said documents Provides, reviews, and/or approves specifications for structure, content, and algorithms for Analysis Data Model (ADaM) datasets Develops and validates programs in one or more of these programming languages: R, Python, SAS® Reviews patient evaluability listings Performs quality control and senior review of ADaMs and TFLs for safety, efficacy, ISS, and ISE and data integrations Prepares and reviews statistical report, statistical section of the clinical study report (CSR), and data safety monitoring boards (DSMBs) / data monitoring committees (DMCs) charters Provides statistical execution and representation for DSMBs/DMCs Serves as statistical lead for regulatory submission Manages Biometrics projects and Biometrics project teams, including status updates of trials, projecting revenue, tracking of project activities, and allocating resources Participates in proposal development, budget development, and bid defenses Carries out line management responsibilities for assigned staff, including performance management and development activities, disciplinary procedures and administrative activities Handles miscellaneous tasks as assigned by management Qualifications And Education Requirements MS or Ph.D. in Statistics/Biostatistics or equivalent with at least 12+ years’ experience as a Statistician (MS) or 8+ years’ experience as a Statistician (Ph.D.) with clinical trial experience and previous experience with a large portion of the statistical content of at least 2 NDAs and at least 6 years of experience managing people/projects.

Proficiency in statistical procedures including non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques. Proficiency in SAS and SAS Macro language. Must have extended knowledge of the procedures of clinical programming and understanding of data management flow in clinical programming. xqbhyrx Effective written and oral communication skills along with strong organizational, interpersonal and project management skills.

Preferred Skills Excellent organizational skills Excellent communication skills, verbal and written Exceptional attention to detail Strong interpersonal skills to drive and oversee a cross-functional team Strong computer skills, including Microsoft Office and use of data management systems Excellent problem-solving skills Effective decision maker – able to exercise good judgment and take appropriate action independently Flexible, team player Proven ability to organize, delegate and effectively prioritize workload and deliverables