(Associate) Director, Biostatistics

Shanghai, China   |   full time   |   Job ID: 8282 

Your main responsibilities are: 

• Represent Statistics in all assigned cross-functional clinical study teams and other projects and holds him/herself accountable for all statistical aspects.
• Serve as the biostatistics lead core team member for all assigned programs.
• Represent Statistics in multiple projects of cross-functional process and standards development/ improvements, and infrastructures initiatives and evaluations.
• Mentor (Associate) Directors and/or Line management of GBS staff in the China team.
• Work as part of a collaborative, cross-functional team with members from other disciplines.
• Provide statistical guidance into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables.
• 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 due diligence projects for business partnerships and serve as contact person in Biostatistics for external partners for assigned studies.
• Keep updated on development of new Chinese regulatory guidelines, statistical methodologies and technologies and serve as SME in Statistics for clinical development.
• Assumes possible line management responsibilities of staff and is responsible for recruiting, developing, and retaining talent.
• 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 12 years (15 years for masters) in the pharmaceutical industry and/or CRO.
• At least 10+ 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 supervision of outsourced activities as well as with the development and execution of outsourcing strategies.
• Excellent knowledge of the China-specific regulatory processes including regulations that regulate and facilitate cross-border data flows.
• Experience in leading answers to health authority questions (FDA, EMA, NMDA) and leading in statistics on regulatory submissions, including developing ISE/ISS packages.
• Excellent knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus), regulatory guidelines (ICH, FDA, EMA, NMDA).
• Excellent knowledge of statistical analysis software (SAS) and sample size calculation software (e.g., EAST and/or NQuery).
• Preferred experience in R or Python.
• Awareness of the bigger picture, strong orientation to quality and timely manner, innovative and solution orientated thinking.
• Ability to thrive working in a fast-paced environment while remaining flexible, proactive, resourceful, and efficient.
• Excellent interpersonal skills, strong teamwork spirits to develop good working relationships with key stakeholders.
• Excellent conflict management and negotiation skills.
• Outstanding analytical skills.
• Ability 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.
• Mindset of precision and high-quality standards, going beyond the obvious to deliver high-quality analyses and support in a challenging and evolving environment.
• Excellent communication skills:

• the ability to express complex analysis in clear language.
• an excellent command of written and spoken English and local language skills.

• Strong experience in using advanced statistical methodologies in designing and analyzing clinical studies.
• Stay in “United, Passionate, and Innovative” to “Translate Science to Survival”.

Your Benefits:

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.