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Head of Data Analytics

Role Responsibilities

The Head of Data Analytics will be responsible for providing direct oversight, effective leadership, and strategic planning to the Statistical Programing and Data Management functions.  These functions will be either Werewolf employees, or resources from a Contract Research Organization (CRO) or Functional Service provider (FSP).  This position will be part of the Clinical Development Team with the primary function of ensuring high quality statistical programming, reporting, and clinical data standards for all Werewolf Therapeutic studies.

Statistical Programming

  • Liaise with various internal and external groups (Clinical, Statistics, Data Management, Regulatory, Pharmacovigilance, and external vendors including CROs and regulatory bodies) for the implementation of programming needed for internal data exploration, and regulatory submissions.
  • Ensure high quality, compliant programming to produce the SDTM/ADaM datasets, tables, and statistical analyses needed for regulatory compliant output with consistency across the clinical programs and on-time delivery.
  • Oversee programming and validation of eCTD submission deliverables including annotated CRFs, define files, reviewer's guides, and computational methods documentation.
  • Ensuring QC of vendor programming deliverables; Ensuring the review of DTA/DTS specifications for external data transfers.
  • Responsible for the design, development, and implementation of technical solutions for integrating, analyzing and reporting clinical data.
  • Review and monitor project timelines, adjust, if necessary, to ensure project can meet both planned and unplanned needs in a timely manner.
  • Supervision and management of statistical programming staff, contractors, and vendors; provide staff with reliable guidance to succeed and grow.
  • Responsibility for programming SOPs and Guidelines development and revision.
  • Update skills continually with respect to evolving industry standards, statistical concepts, regulatory expertise, and therapeutic area knowledge.

Data Management

  • Leads oversight of data management for outsourced clinical trials including project management, vendor management, coordination of internal reviews and data cleaning process, and approval of deliverables.
  • Ensures that staff levels are adequate in quality and quantity to meet the forecasted workload. Recommends changes if necessary and justifies them in accordance with company policy.
  • Oversees CRO/Vendor activities to ensure GCP compliance, ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices.
  • Oversees data management activities to maintain consistency across trials/development projects: including Case Report Form (CRF) design and standards, Data Management Plans, CRF annotation and completion guidelines, edit check programs/specifications, data entry and query status tracking, and database closure.
  • Develops and maintains data management SOPs and policies as required to maintain overall quality and consistency of Data Management.
  • Oversees database design and production, ensuring that CROs, vendors and internal staff meet the highest quality standards per SOPs.
  • Oversees the tracking of important study metrics such as data entry, source verification, and query resolution status.
  • Supervision and management of data management staff, contractors, and vendors; provide staff with reliable guidance to succeed and grow.
  • Update skills continually with respect to evolving industry standards, statistical concepts, regulatory expertise, and therapeutic area knowledge.

Qualifications

  • Bachelor’s degree in computer science, life science, mathematics or related field or equivalent and relevant formal academic/vocational qualification.
  • Minimum 10 years of statistical programming and/or data management experience in CRO, biotech, or pharmaceutical in the pharmaceutical/biotechnology industry and exposure to global clinical data systems and processes with at least 5 years' management experience.
  • Working knowledge with numerous EDC (Electronic Data Capture) systems for study development.
  • Experience in gathering requirements and preparation of specifications for database systems and integrations e.g. ePRO, laboratory data uploads, supply management, IVRS, IWRS, etc. would be highly regarded.
  • Knowledge of all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines – e.g. clinical operations and biostatistics.
  • Knowledge of regulatory and industry standards (e.g. ICH/FDA guidelines, GCP, CDISC standards, GCDMP, 21 CFR 11, MedDRA and WHO Drug dictionaries etc.) and their application to Data Management practice.  Prior experience filing a NDA/MAA/BLA preferred.
  • Strategic leadership in a cross-functional team setting with extensive experience in an outsourced model, EDC databases, CDASH, CDISC, and SDTM/ADaM standards, medical terminology, medical coding dictionaries, and quality control processes.
  • Strong hands-on SAS programing skills and working experience in CDISC including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as in industry standards for electronic submission of data to FDA.
  • Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro languages.
  • Strong leadership, interpersonal, organizational, and multi-tasking skills, and ability to work within cross-functional teams.
  • Ability to manage multiple initiatives and shifting priorities within a small company environment; excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.


For further information or to be considered for this position, please contact
jobs@werewolftx.com

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