Director Biostatistics

Passion for Innovation. Compassion forPatients.

With over 7 years ofexperience and more than 200 employees in over 4 countries,Sigma-Chi is dedicated to discovering, developing, and deliveringnew standards of care that enrich the quality of life around theworld.

In Europe, we focus on two areas: Thegoal of our Specialty Business is to protect people fromcardiovascular disease, the leading cause of death in Europe, andhelp patients who suffer from it to enjoy every precious moment oflife. In Oncology, we strive to become a global pharma innovatorwith competitive advantage, creating novel therapies for peoplewith cancer.

Our European headquarters are inLeipzig, Germany, and we have affiliates in 3 European countriesand USA.

We are looking for a:

The position holder is responsible for leadingbiostatistical strategy and accountable for all biostatisticalactivities for Medical Affairs, Health Economics and OutcomeResearch and Health Technology Assessment for at least one compoundby contributing to evidence generation plan, pricing authorities’interactions and scientific communication.

Theposition holder will be responsible to coordinate otherbiostatisticians assigned to the same compound as well as interactand ensure alignment with data management and statisticalprogrammers.

The position will either be basedin one of our offices in Europe or from home within one of thesecountries.

Roles andresponsibilities:

Project Responsibility

• Accountable for all functional activities forat least one Compound
• Act as the functionalexpert within the assigned program, ensuring that activities forEvidence Generation are scientifically sound and that the evidencegenerated meets requirements of internal and externalstakeholders
• Take responsibility as projectlead for all deliverables performed by biostatisticians across theglobal / regional evidence generation activities
• May lead critical studies from design to analysisexecution and interpretation and contribute to documents submittedto Regulatory or Pricing Authorities

Operational Excellence andInnovation

• Sponsor, leadand participate in initiatives to improve the harmonization andefficiency of processes and develop and implement innovativesolutions
• Maintain current knowledge ofindustry best practice in statistical methodology
• May act as Subject Matter Expert for Biostatistics, byproviding guidance and support to team members andcross-functionally
• Monitor regulatory guidanceand industry best practices to formulate proposals for newfunctional standards

LineManagement activities

• Leada team including recruitment, coaching, mentoring, peopledevelopment, talent & performance management
• May lead a cross functional project team
• Responsible for providing senior governance, direction,and execution of oversight of vendor delivery, to ensure compliancewith the protocol, external/internal standards, regulatory andother relevant guidelines
• Responsible for CROselection

Personalskills and professional experience:

• Master’s degree or PhD (preferable) instatistics, mathematics or related fields
• Atleast 10 years of experience as statistician (with at least 3 inPharma) supporting drug development and/or post marketing inClinical research, Pharmaceutical company, CRO or Medical Devicesetting
• Experience in oncology TherapeuticArea or in late phase projects is an advantage
• Extended and up-to-date knowledge of statistical methodsrelated to clinical studies and to HEOR/HTA applications
• Knowledge of CDISC standards and statistical softwaresuch as SAS and/or R
• Extended knowledge andunderstanding of the principles, concepts, methods, and standardsof Clinical Research
• Demonstrated expertise instudy design, conduct and execution
• Excellentcommunication skills, both oral and written, in explaining insimple terms complex concepts
• Good negotiationand project management skills
• Demonstratedentrepreneurship and leadership and proactive problemsolving
• Ability and interest to workremotely

Working at Sigma-Chi is more than just ajob – it is your chance to make a difference and change patients’lives for the better. We can only achieve this ambitious goaltogether. That is why we foster a culture of mutual respect andcontinuous learning, with a strong commitment to inclusion anddiversity. Here, you will have the opportunity to grow, thinkboldly, and contribute your ideas. If you have a proactive mindsetand passion for addressing the needs of patients, we eagerly awaityour application.

For more information:www.sigma-chiconsulting.com

Job Category: Director

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