Fecha: 9 feb 2025
Mission
The Senior Statistician will be responsible for the design and statistics of clinical trials and clinical development projects within Almirall. The Senior Statistician will partner with senior scientists in clinical (Global Development and Global Medical Affairs), safety, regulatory, market access, and research on clinical development projects, pricing and reimbursement dossiers, and publications.
Tasks and Responsibilities
Clinical Development:
* Member of clinical team, collaborating in preparation of Clinical Development Plans according to the Target Product Profile.
* Participates in the Synopsis and Protocol development, being accountable and author of statistical sections of protocols and other regulatory documents.
* Prepare the statistical analysis plan(s) (SAP) according to the study protocols, and also Table, Figures, and Listings (TFL) formats. Supervise programming activities relating to statistics.
* Accountable and author of the Statistical Report from the study results, with active collaboration in the revision of the Clinical Study Report.
* Contribute to Health Authority & Ethics Committee Documents during approval procedures, addressing statistical methodology used in clinical trials, dossier submissions, and interpretation of results.
* Oversee the deliverables from Statistical & Programming CROs. Lead the generation of health authority submission datasets and associated documentation.
* Participate actively, when needed, in Health Authority meetings and Advisory Boards, Publications, and other presentations.
* Collaborate with Market Access in preparing the Value Dossier Proposition to the HTA, maximizing available data and using appropriate methodology to defend proposals.
Statistical Methodology:
* Investigate and apply new statistical methodologies to facilitate increased quality and efficiency in clinical development.
* Analyze and evaluate new statistical software.
* Hold meetings with external advisors and regulatory authorities when required, aiming to update and optimize statistical methodologies used and guarantee their correct application.
Statistical Activities Performed by External Companies (CRO; Academic Organization, etc.):
* Ensure the delivery of the CRO activities contracted out, with deliverables according to predefined quality, timelines, and cost. (Statistical sections of the protocol, SAP, statistical analyses, and preparation of the statistical reports)
* Evaluate Statistics CROs.
* Supervise Programming activities.
* Collaborate with companies specialized in Market access activities and knowledge.
Education
Education, Experience and Skills:
* PhD in statistics or a minimum of 8 years of relevant pharmaceutical industry experience working as a statistician.
* Proven track record in statistical leadership and implementation of innovative design and analysis methodology in the translational research area.
* Experience with a wide range of advanced statistical methods, strong analytical capabilities, and data exploration skills.
* Experience with statistical software packages such as R, SAS, and JMP.
* Broad interest and ability in applying statistics to facilitate the quantitative decision-making process.
* Good communication, presentation, and consultancy skills, with a creative mind and good problem-solving skills.
* Advanced knowledge of the pharmaceutical industry, including understanding of the clinical drug development process and associated documents.
* Strong collaborative skills and ability to work with a cross-functional team.
Values
* Caring
* Dynamic
* Expert
* Dedicated
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