Associate Director, Statistical Programming

Grifols

Dublin, Ireland

The Associate Director provides Statistical Programming leadership and expertise in support of clinical development and post‐marketing activities for multiple therapeutic areas. Participates in the development, registration, and life cycle management of Grifols products.

Drives standardization within the Biometry group, innovating to develop processes/systems/tools designed to improve automation and efficiency of all aspects of reporting of clinical trials – including standard checking of deliverables generated by Contract Research Organizations (CROs).

Contributes strategically to project decisions with a focus on pre-study planning, reporting and submission preparation within and across projects.

KEY RESPONSIBILITIES

The duties and responsibilities include, but are not limited to, the following:

Provides specific functional expertise, leadership and strategic thinking within Biometry.
Responsible for ensuring overall quality of analysis and reporting deliverables for global Phase I‐IV clinical trials and research publication efforts.
Acts as a lead programmer, generating/validating CDISC compliant statistical analysis database and outputs (i.e., tables, listings, figures, and inferential statistical output) using SAS, R or other software.
Leads the development and adaptation of new Statistical Programming tools/processes in support of Grifols drug development.
Responsible for establishing and maintaining policies, standards and guidance for Statistical Programming operations in adherence with ICH and regulatory requirements.
Oversees projects which relate to improving processes and quality and efficiency of clinical reporting within the Biometry group.
Determines efficient utilization of Statistical Programming resource by leveraging both in‐house staff and external vendors. Provides input on optimal resource utilization and capacity.
Manages outside CROs and consultants within the programming function, as needed. Maintains constant and open communication to make sure timely and quality deliverables and support CRO selection processes.
Drives the development of tools for continual assessment of CRO contributions to clinical trials.
Provides support in the development of programmers within the Statistical Programming and Data Management groups.
Provides Statistical Programming consultancy to colleagues, leveraging project management, technical leadership abilities and submission requirements knowledge, with a hands-on and collaborative approach.
Contributes to the hiring and mentoring of statistical programmers within the Biometry group.

KEY COMPETENCIES

Expert knowledge of SAS, R or Python.
High degree of expertise in CDISC and other industry standards, tools and regulatory requirements.
Demonstrate a high degree of independence, technical skills, with the ability to influence the team, internal stakeholders and external vendors to achieve results with minimal to no supervision.
Ability and experience to determine overall programming strategy for the Biometry group.
Demonstrate strong problem solving and risk‐mitigation skills. Is a strategic and creative thinker.
Excellent interpersonal, verbal and written communication skills.
Strong attention to detail and excellent organizational skills.
Comfortable working in a dynamic, fast-paced environment.

Qualifications and Experience

Bachelors’ degree or higher in computer science, bioinformatics, biostatistics or related field.
Requires a PhD with a minimum of 10 years of clinical development experience in the pharmaceutical/biotech industry or an MSc with a minimum of 12 years’ experience or a BSc with a minimum of 15 years’ experience.

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