Job Description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

The Associate Director of Biostatistics provides leadership and guidance as the statistical expert on project teams or within a therapeutic area. He/she is accountable for all statistical aspects of assigned clinical studies including trial design, protocol development, analysis and interpretation of results for publications and submissions. Assurance of scientific validity and quality deliverables according to requirements of international regulatory agencies. The Associate Director may mentor junior statisticians, interns or contractor statisticians and will report to the Director of Biostatistics.

What you'll do:

• Responsible for cross functional participation in study design, clinical protocol development, statistical methodology and modeling, sample size estimations, endpoint specification, study logistics, randomization plans, interim analyses, and statistical analysis plans.
• May be the statistical member of Data Safety Monitoring Committee to assess product safety.
• Responsible for execution of statistical analysis, statistical programming procedures and production of tables, listings and figures either directly or through management of CRO’s.
• Reviews and participates in Quality Control of publications, reports, regulatory documents. May collaborate other statisticians and or programmers to ensure quality assurance of data outputs.
• Authors statistical sections of protocols, reports, manuscripts and regulatory documents.
• Represents Grifols as a statistical expert at international regulatory agency meetings to support rationale and questions of statistical plans /methodologies for how data is planned to be or has been analyzed.
• Member of therapeutic area Adboards and Publication Planning teams on future or current clinical programs.
• Supports the biometry department with the optimization of internal processes and procedures, in addition to ensuring adherence to procedures and regulatory guidance for statistical activities across Grifols.

What you'll bring

• Skills/Qualifications/Education Requirements: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
• PhD or MS degree in statistics, biostatistics, mathematics or related field
• 12 years’ experience in biostatistics in the biotechnology, pharmaceutical, or health related industry including significant interactions with regulatory bodies. 10 years’ experience in clinical research and development required and some experience with a Pharmaceutical Sponsor company.
• Expert knowledge of a wide range of statistical methodology, including experimental design, linear models, mixed models, categorical data techniques, non-parametric statistics, and survival analysis.
• Expert knowledge of advanced statistical and probability theory.
• Expert knowledge of regulatory guidelines related to trial design, analysis, reporting, data structure, and electronic submissions. Broad knowledge of clinical trials and the statistical applications in clinical trials. Strong knowledge of ICH GCP and FDA guidelines.
• Broad knowledge of medical background to be able to communicate with medical personnel regarding the statistical issues arising in the clinical trials.
• Solid skills in computer programming (preferably SAS or R).
• Excellent interpersonal communication skills (verbal and written) in English.

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates are (3%/ 5%/ 7%) and company will match
• Private Medical Insurance for the employee
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities - Social activities eg. Padel, Summer Events

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you

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Location: Grange Castle International Business Park, Grange, Clondalkin, Co. Dublin, D22 K2R3