Senior Director Biostatistics

vor 1 Monat

Frankfurt, Deutschland Proclinical Vollzeit

Proclinical is seeking a Senior Director of Biostatistics. This role will be a key player in the cross-functional clinical study teams. The successful candidate will provide statistical guidance, carry out sample size calculations, run the creation of plans for statistical analysis and oversee outsourced statistical activities. This role also involves potential line management responsibilities and the opportunity to contribute to departmental strategies.

Responsibilities:

Work alongside statistics in clinical study teams and projects.Serve as the biostatistics lead for assigned programsProvide statistical guidance into clinical development plans, study protocols, reports, regulatory submission documents, and publicationsPerform and verify sample size calculationsLead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis resultsParticipate in planning for health authority meetings and development of associated documentsOversee outsourced statistical CRO activities and deliverablesSupport and participate in the development of departmental strategies and cross-functional initiativesProvide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programmingWork closely with Clinical Data Manager to ensure data quality standards are met

Key Skills and Requirements:

PhD or Masters in BioStatistics, Mathematics or another equivalent fieldWorking experience in the pharmaceutical industryExperience in overseeing statistics staff and representing Biostatistics in a multidisciplinary team.Knowledge in planning, creating and analysing trials from phase I-IV, including scientific publicationsProven history knowledge to answer health authority questions (FDA, EMA) and leading in statistics on regulatory submissionsKnowledge of clinical development, study designs, advanced statistical methods, regulatory guidelines (ICH, FDA, EMA)Knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)Understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plusExcellent analytical skills and communication skillsProficiency in both written and spoken English


If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan on h.hennigan@proclinical.com.



Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

  • Senior Director Biostatistics

    vor 1 Monat

    Frankfurt am Main, Hessen, Deutschland Proclinical Vollzeit

    Senior Director of BiostatisticsProclinical is seeking a highly experienced Senior Director of Biostatistics to join their team. This role will involve providing statistical guidance, overseeing statistical activities, and contributing to departmental strategies. The successful candidate will be a key player in cross-functional clinical study teams, working...

  • Senior Director Biostatistics

    vor 1 Monat

    Frankfurt, Deutschland Proclinical Vollzeit

    Proclinical is seeking a dedicated and innovative individual for a Biostatistics position. The successful candidate will focus on creating and maintaining processes and work quality related to clinical trials, while making sure these are in line with regulatory requirements. This role is integral to driving biostatistics strategy in line with objectives and...

  • Senior Director Biostatistics

    vor 1 Monat

    Frankfurt am Main, Hessen, Deutschland Proclinical Vollzeit

    Proclinical is seeking a dedicated and innovative individual for a Biostatistics position. The successful candidate will focus on creating and maintaining processes and work quality related to clinical trials, while making sure these are in line with regulatory requirements. This role is integral to driving biostatistics strategy in line with objectives and...

  • Senior Biostatistics Director

    Vor 3 Tagen

    Frankfurt am Main, Hessen, Deutschland AL Solutions Vollzeit

    AL Solutions is seeking a highly experienced Senior Biostatistics Director to join our team in Germany. As a key member of our biometrics team, you will be responsible for leading the statistical aspects of clinical development plans, studies, and submission activities.Main Responsibilities:Mentor and Lead the Project Team: Foster a productive work...

  • Senior Biostatistics Director

    Vor 4 Tagen

    Frankfurt am Main, Hessen, Deutschland AL Solutions Vollzeit

    AL Solutions is seeking a highly experienced Senior Biostatistics Director to join our team in Germany. As a key member of our biometrics team, you will be responsible for leading the statistical aspects of clinical development plans, studies, and submission activities.Main Responsibilities:Mentor and Lead the Project Team: Foster a productive work...

  • Director Biostatistics Process Excellence

    vor 3 Monaten

    Frankfurt am Main, Deutschland Proclinical Vollzeit

    Proclinical are partnering with a biotech consultancy who are recruiting for an individual to join their team. This role is on a permanent basis and is located in Frankfurt. The opening position is for a Director Biostatistics Process Excellence. **Responsibilities**: - Guide the GBS process development initiatives to develop the optimal methods to improve...

  • Director Biostatistics

    vor 3 Monaten

    Frankfurt am Main, Deutschland Proclinical Vollzeit

    Proclinical are recruiting a Director Biostatistics - Germany for a biotech consultancy. This role is on a permanent basis with the ability to work remotely from anywhere in Germany. *** **Responsibilities**: - Supervise outsourced statistical CRO actions and deliverables, guaranteeing highest quality. - Assist with and partake in the development of...

  • Associate Director

    vor 3 Monaten

    Frankfurt, Deutschland AL Solutions Vollzeit

    Taylor Young is partnered with a Global Pharmaceutical company that is looking to Broaden their biometrics team in Germany and is hiring for a highly experienced Associate Director focusing on biostatistics. This an incredible and exciting opportunity to join a leading international organization that specialises in multiple areas and has an experienced and...

  • Associate Director

    Vor 4 Tagen

    Frankfurt am Main, Hessen, Deutschland AL Solutions Vollzeit

    AL Solutions is seeking a highly experienced Associate Director to lead our biostatistics team in Germany. As a key member of our organization, you will be responsible for leading one or more indications/projects in a Therapeutic Area with minimal supervision.Main Responsibilities:As a Statistical Project Leader in Biostatistics, you will lead one or more...

  • Associate Director

    vor 18 Stunden

    Frankfurt am Main, Hessen, Deutschland AL Solutions Vollzeit

    Job Summary:AL Solutions is seeking a highly experienced Associate Director to lead our biostatistics team in Germany. As a key member of our organization, you will be responsible for leading one or more indications/projects in a Therapeutic Area with minimal supervision.Main Responsibilities:As a Statistical Project Leader in Biostatistics, you will oversee...

  • Associate Director

    vor 18 Stunden

    Frankfurt am Main, Hessen, Deutschland AL Solutions Vollzeit

    Job Summary:AL Solutions is seeking a highly experienced Associate Director to lead our biostatistics team in Germany. As a key member of our organization, you will be responsible for leading one or more indications/projects in a Therapeutic Area with minimal supervision.Main Responsibilities:As a Statistical Project Leader in Biostatistics, you will oversee...

  • Senior Biostatistics Manager

    Vor 5 Tagen

    Frankfurt am Main, Hessen, Deutschland AL Solutions Vollzeit

    Job SummaryAL Solutions is seeking a highly experienced Director of Biostatistics to join our team in Germany. As a key member of our biometrics team, you will be responsible for leading the statistical aspects of clinical development plans, studies, and submission activities.Key ResponsibilitiesMentorship and Team Leadership: Provide guidance and support to...

  • Associate Director

    vor 3 Monaten

    Frankfurt, Deutschland AL Solutions Vollzeit

    Taylor Young is partnered with a Global Pharmaceutical company that is looking to Broaden there biometrics team in Germany and is hiring for a highly experienced Associate Director focusing on biostatistics. This an incredible and exciting opportunity to join a leading international organization that specialises in multiple areas and has an experienced and...

  • Associate Director

    vor 3 Monaten

    Frankfurt, Deutschland AL Solutions Vollzeit

    Taylor Young is partnered with a Global Pharmaceutical company that is looking to Broaden their biometrics team in Germany and is hiring for a highly experienced Associate Director focusing on biostatistics. This an incredible and exciting opportunity to join a leading international organization that specialises in multiple areas and has an experienced and...

  • Director of Biostatistics

    Vor 5 Tagen

    Frankfurt am Main, Hessen, Deutschland AL Solutions Vollzeit

    Job SummaryAL Solutions is seeking a highly experienced Associate Director of Clinical Development to join our team in Germany. As a key member of our biometrics team, you will be responsible for leading the development of clinical trials and ensuring the quality and integrity of our statistical analysis.Main ResponsibilitiesMentorship and Team Leadership:...

  • Senior Art Director

    vor 3 Monaten

    Frankfurt am Main, Deutschland DESIGNERDOCK Vollzeit

    Senior Art Director (m/w/d) - Frankfurt - Art Direktion (offline) - F39464 - DD Frankfurt - Lutz Augustin - Share - Tweet - Copy

  • Senior Art Director

    vor 3 Monaten

    Frankfurt am Main, Deutschland DESIGNERDOCK Vollzeit

    Senior Art Director (m/w/d) - Frankfurt - Art Direktion (offline) - F39497 - DD Frankfurt - Alexander Haase - Share- Tweet- Copy

  • Knowledge Senior Director

    vor 1 Monat

    Frankfurt, Deutschland Boston Consulting Group Vollzeit

    WHAT YOU'LL DOAs the Knowledge Senior Director of the Risk & Compliance Practice Area, you will partner with leadership in shaping the strategic priorities for the Practice Area. You will lead the global Risk & Compliance Knowledge Team, driving the strategy and execution of the portfolio of knowledge assets, services, and professionals as well as leverage...

  • Senior Art Director

    vor 3 Monaten

    Frankfurt am Main, Deutschland DESIGNERDOCK Vollzeit

    Senior Art Director (m/w/d) für eine kleine und feine Agentur - Frankfurt - Art Direktion (offline) - F39595 - DD Frankfurt - Lutz Augustin - Share- Tweet- Copy

  • Regular Oder Senior Art Director

    vor 3 Monaten

    Frankfurt am Main, Deutschland LePetitMax Vollzeit

    **LEPETITMAX** - das kleine Maximum - steht für hohen kommunikativen Anspruch und sucht Verstärkung in der Kreation. Wir sind eine kleine, inhabergeführte Design - und Kommunikations-Boutique im Frankfurter Westend. Wir haben uns außergewöhnliche 360°-Kommunikation mit hohem Anspruch an Design und Kreation zur Aufgabe gemacht - sowohl für dynamische...