(+45) 29 44 00 80 / kontakt@beirholmsearch.dk

Head of Biostatistics

Head of Biostatistics
oktober 10, 2019 Hanne Beirholm
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The Biostatistics team plays a critical role in advancing the new medicines at Genmab and as Head of Biostatistics you will be accountable for all statistical activities of the development of our innovative pipeline within oncology.

Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.

The Role

The Biostatistics team plays a critical role in advancing the new medicines at Genmab and as Head of Biostatistics you will be accountable for all statistical activities of the development of our innovative pipeline within oncology.

You will be responsible for defining the strategy and the processes within the statistical area, which includes driving innovative and efficient trial designs, clinical trials conduct and submissions, and ensuring innovation, quality and scientific validity of our trials.

You will ensure design, data analysis and interpretation (particularly regulatory and marketing claim substantiation, during clinical evaluations, studies, and trials) are high quality and in compliance with regulatory body standards.

As Head of Biostatistics you will lead a team of 7 highly competent and experienced Biostatisticians. It is essential that you can lead and inspire a highly engaged and committed team.

You will be part of the Clinical Operations Leadership Team (COLT) defining the overall strategy and development areas within Clinical Operations and partner with senior management, clinicians, pharmacologists, and translational research to support clinical development within Oncology.

This is a fantastic opportunity to join Genmab – a highly innovative biotech company with a rich pipeline and at the forefront of cancer therapy development.

It is a small organization with a short chain of command. You will have high visibility and possibility to shape not only the role but add a footprint on the pipeline – so is it time to take the next important step in your career?

Main Responsibilities

  • Oversee, mentor, and help develop a group of internal Biostatisticians and Consultants.
  • Core member of scientific teams responsible for determining strategy and delivering results in a timely and high quality environment.
  • Develop and implement strategy for the improvement of productivity and standardizing of biostatistical activities.
  • Interface closely with Statistical Programming and Data Management to ensure end to end data quality.
  • Bring innovative statistical thinking and methods to help drive the enhanced drug discovery and development, and lead initiatives that improve understanding and application of statistical methods utilizing simulation, Bayesian methods etc. to design efficient trials and co-development of companion diagnostics.
  • Provide guidance on appropriate design, management, analysis and reporting of RWE trials.
  • Interact with regulatory agencies to support accelerated clinical development options.
  • Contribute to planning of submissions, and post-submission strategies, preparations and defences.
  • Lead initiatives to improve understanding and application of statistical methods.
  • Strong insight into the Business needs and seek out areas where statistics add most value to maximize success of our compounds.
  • Ensure that flexible and rapid responses are provided for statistical requests.
  • Identify and assist in the resolution of bottlenecks for study/project teams.
  • Manage resources, set priorities, and ensure consistency and adherence to standards therein.
  • Represent Biostatistics in the Protocol Review Committee (PRC)
  • Drive/establish the creation/maintenance of state of the art processes and SOPs within the biostatistical areas.
  • Development of specifications/requirements for outsourcing activities related to the biostatistical area and overall accountable for oversight of activities provided by consultants, CRO´s and other vendors.
  • Shape Biostatistics function to create and leverage programs, policies, and procedures to provide value-adding solutions.
  • Ensure that all teams and employees work toward the same objectives and work as one team
  • Stay up to date on the latest relevant scientific literature and translate your learning into evolving best practices at Genmab.
  • Identify external statistical experts for consultation.
  • Act as key statistical consultant within Genmab.
  • Represent the Biostatistical group in cross functional working groups.
  • Promote collaborative relations with stakeholders, vendors, consultants, and CRO´s in a global setting.
  • Work collaboratively with colleagues /partners in the EU, the US and Japan and bring cultural diversity into play.

 

Qualifications

  • At least 10 years of experience in pharmaceutical development and applied biostatistics, oncology experience preferred.
  • At least 5 years of management experience leading biostatistics group.
  • Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred.
  • Knowledge of FDA, EMA, and ICH guidance for drug development pertaining to statistics
  • Experience with the relevant regulatory requirements for biostatistics processes and SOPs
  • Experience with regulatory submissions including BLAs and previous experience in dealing with health authorities such as discussions/negotiations in filing strategies
  • Familiarity with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
  • Demonstrated ability to work independently, handle multiple priorities within timelines, and collaborate with other functions to resolve issues and improve efficiency
  • Excellent inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators
  • Strong communication skills with the ability to influence widely and work collaboratively with clinical project teams and senior management are required.
  • “Go do” attitude, creative, proactive, enthusiastic, “outside-the-box” and goal orientated.
  • Significant experience in managing to deliver results.
  • Demonstrated ability to collaborate with a diverse and global group of people including but not limited to biostatisticians, clinicial, scientists, translational research

A team player, enthusiastic, passionate about bringing important new innovative products to patients with oncology. Actively continue to further build the group of highly qualified Biostatisticians.

 

Other

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful applicant a challenging position where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.

Information and application:

If you would like additional information about this position before applying using the link, please contact Hanne Beirholm, Beirholm Search. Tel. +4529440080 /mail: kontakt@beirholmsearch.dk





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