20 beste Stellen als data science in eltville, he – aktuell auf Personalsuche

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data science jobs near eltville, he

Associate Director Biostatistics (Oncology)

BioNTech AG -
Mainz

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Details zur Stelle

Vollzeit

Qualifikationen

Statistik-Software
Doktorat
SAS
Master
Führungserfahrung

Vollständige Stellenbeschreibung

Mainz, Germany | full time | Job ID: 11339

About the role:

As Associate Director Statistical Programming you will be responsible for representing Statistics in all assigned cross-functional clinical study teams and other projects and holding accountability for all statistical aspects, as well as for providing statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables.

Your main responsibilities are:

Work as part of a collaborative, cross-functional team with members from other discipline
Perform and/or verify sample size calculations
Lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results
Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses
Oversee outsourced statistical CRO activities and deliverables ensuring highest quality and in a timely manner
Support and participate in the development of departmental strategies
Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming
Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met

What you have to offer:

PhD or Masters in (Bio)Statistics, Mathematics or equivalent
Minimum 5 years (8 years for masters) in the pharmaceutical industry and/or CRO
At least 3 years of work/leadership experience, overseeing statistics staff (internal as well as outsourced) and in representing Biostatistics in a matrix organization and in a multidisciplinary team
Experiences in planning, conducting and analyses of oncology or infectious diseases trials from phase I-IV, including scientific publications
Experience in answering health authority questions (FDA, EMA) and in leadings statistics on regulatory submissions, including developing ISE/ISS packages
Good knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus), regulatory guidelines (ICH, FDA, EMA)
Good knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)
Very good understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus
Very Good analytical skills and bility to analyze complex issues to develop relevant and realistic plans, programs, recommendations, risk mitigation strategies, and the ability to communicate them to cross functional colleagues
Strong drive for achieving high quality working results in a timely manner, while always safeguarding ethical standards in work and behaviors
Very good communication skills:
- the ability to express complex analysis in clear language
- an excellent command of English written spoken

Your benefits and remuneration:

If the position is filled in the US, the Expected Pay Range is XXX,XXX/year to XXX,XXX/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Compensation at other locations may vary significantly.

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com

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Erweiterte Suche

data science Jobs in eltville, he

Associate Director Biostatistics (Oncology)

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