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.

POSITION SUMMARY

As a Biostatistician you will be 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 quality and scientific validity of statistical deliverables according to the requirements of international regulatory agencies.

KEY RESPONSIBILITIES

Primary responsibilities for role

• Serves as biometry contact to the clinical development department, providing input into clinical trial design and execution. Writes statistical analysis section of protocol and clinical study reports

• Analyses clinical trial data, producing accurate results representing the outcome of the trial. Validates statistical output. Interprets and clearly communicates statistical results and concepts.

• Supervises external statistical input into trials and evaluates biostatistical deliverables provided by CROs and independent consultants.

• Reviews critical data management and programming documentation, ensuring that data collection and reporting meet regulatory standards and guidance.

• Writes Statistical Analysis Plans.

• Leads Blinded Data Review meetings.

• Oversees the process of randomization schedule generation.

• Provides input into statistical SOPs and general standardization efforts within the clinical development department (e.g. statistical methodology standards, standard data presentations, standard CRFs).

• Supports Regulatory Authority meetings (e.g. pre-IND meetings; Represents company at FDA or other agency with regard to methodological issues and support of results).

Person Specification

• Excellent knowledge of statistical methodology, including experimental design, linear models, categorical data techniques, nonparametric statistics, and survival analysis.

• Excellent knowledge of ICH and FDA guidelines related to trial design, analysis, and reporting of clinical trials and estimand framework.

• High degree of expertise in CDISC specifications for SDTM and ADaM data.

• Solid skills in computer programming (preferably SAS or R).

• 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.

• Strong communication and interpersonal skills.

• Ability to work in multiple therapeutic indications and able to handle multiple projects across these therapeutic areas.

• 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

PhD or Masters’ degree in statistics or related field.

Requires a PhD with a minimum of 8 years of clinical development experience in the pharmaceutical/biotech industry or an MSc with a minimum of 10 years’ experience.

Our Benefits Include:

• Highly competitive salary

• Group pension scheme - Contribution rates are 5% employer and 5% employee

• 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 Event

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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Learn more about Grifols (http://www.grifols.com/es/web/international/home)

Req ID: 514953

Type: Regular Full-Time

Job Category: Clinical Trials