Statistical Programmer 1

**Date**:9 Nov 2023

**Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain

**Company**:Almirall

**Mission**:
Overview and analyze the required statistics for clinical studies carried out by Almirall S.A.

**Tasks and Responsibilities**:
**Participation in clinical trials and clinical development projects**
- Revise study protocols.
- Revise Study critical documentation: Case Report Form (eCRF / paper CRF) designs, vendors specifications and overread guidelines, questionnaires and patient diaries, annotated eCRF / CRF, table descriptions and database notes, and vendors data export specifications.
- Generate random assignments based on the Clinical Trial Manager and Statistician request.
- Approve Statistical Programming Plan (SPP).
- Develop and validate statistical analysis programs in accordance with the Statistical Analysis Plan (SAP) or equivalent.
- Perform Test Runs, Ongoing analysis, and Blind Data Review Meeting listings if needed
- Document analysis databases (SAS Datasets).
- Write and approve Statistical Programming Report (SPR).
- Integration of clinical trials in project databases and perform statistical programs for their use (meta-analysis, analysis by sub-groups, etc).
- Projects Data Mining.
- Creation of SAS datasets in CDISC (SDTM and ADAMs) format for submission of data to regulatory agencies.

**Coordination of statistical programming activities performed by external companies (Contract Research Organizations, CRO)**
- Provide the necessary expertise to perform statistical programming tasks.
- Provide statistical programming standards for performing SPP and subsequent revision and approval.
- Revise and approve the final documentation of the derived databases (SAS Datasets) and statistical programs.
- Revise and approve the Statistical Programming Report.
- Manage the creation of SAS datasets in CDISC (SDTM and ADAMs) format for submission of data to regulatory agencies.

**Implementation of new statistical methodologies**
- Assess, from a programming point of view, the feasibility of programme development for new models / statistical methodologies.
- Develop standard programs (macros and libraries) for new models / statistical methods
- Hold meetings with external advisers, when necessary, for the development and implantation of new analysis programs.
- Collaborate actively in the description of functional requirements.
- Coordinate project development.

**Technical support to other groups from Global Clinical Development, and to the Company in general**
- Collaborate with the Statistics group in all studies requiring programming use. Collaborate with the Clinical Software Development group in the designing of future databases, both internal (Raw data) and submission (CDISC) following international standards.
- Perform analyses of drug stabilities.
- Provide statistical programming technical support to the members of Statistics, Data Management, Clinical Software Development, Clinical Trial Management, Global Marketing and Medical Affairs (GM&MA), Corporate Drug Safety (CDS), Therapeutic Area, New Therapeutic Areas & Licensing, the rest of Global Development Division and other R&D departments and areas in the company.
- Collaborate technically with the Global Data Management & Project Information (GDM&PI).

**Writing, modifiying and revising working procedures**
- Know, revise and implant international statistical programming standards.
- Write and update Standard Operating Procedures (SOP) for Statistical Programming.
- Know and collaborate in the writing and revising of SOPs in which Statistical Programming is involved.
- Actively collaborate with the rest of the staff in the Global Clinical Development (GCD) department in coordinating all common activities, in order to improve the efficiency of the SOPs and the quality of the final products.

**Internal and external training (attending courses and national and international congresses)**
- Participate actively in internal training sessions (GCD and Clinical Statistics).
- Collaborate in presenting works at congresses and in journals.
- Organise courses and seminars about basic concepts or special statistical programming issues for R&D staff and the Company. Participate in statistical associations, in national and international congresses and courses about methodology and Clinical Investigation statistical techniques, in order to ensure continuous training and regular updating of required expertise.

**Education**:
Degree in Statistics.

**Experience**:

- Minimum 1 year of experience in statistical programming
- Experience in SAS programming
- Experience in the implementation of new statistical methodologies
- Experience in pharmaceutical sector is a plus
- Project Management
- Good stakeholder management, collaborating with other business areas
- Fluent in English, Spanish is a plus

**Values**:

- Care; we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
- Courage; we challeng