Director, HTA Statistics

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Organisation
MSD International GmbH
Location
Zürich, Switzerland
Application Deadline

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

You will be part of the BARDS organization which has a presence in the US, Europewide and Asia Pacific. By joining our company, in this role you will apply your skills and experience in support of developing scientifically based arguments aiming to provide fair accessibility to our company’s drugs and vaccines making a real difference in patient’s lives.

The Biostatistics and Research Decision Sciences (BARDS) organization has a proud record of providing comprehensive analytical and methodological expertise to support our company’s strategic goals. Our quantitative scientists aspire to maintain the highest quality output while adopting the most efficient and effective scientific and operational procedures that will promote breakthrough innovation, collaboration and professional activity.

Description

Reporting to the Executive Director and Head of BARDS Health Technology Assessment (HTA) Statistics, the Director, HTA Statistics will provide biostatistical and operational leadership to a team of statisticians (at least 3 direct reports) in developing and coordinating statistical activities in support of HTA projects, including HTA submissions. This position requires broad knowledge of clinical drug development and expertise in relevant areas of biostatistics and ideally with experience in supervising or mentoring biostatisticians.

Key responsibilities for the position

  • Provide biostatistical and operational leadership to sustain a high performing team supporting HTA strategies, analyses, and submissions to meet/exceed stakeholders’ expectations
  • Foster a team environment that focuses on collaboration and people development
  • Implement departmental objectives, and manage resource and operational challenges
  • Promote the development and application of innovative and value-added statistical methods
  • Interacts with multidisciplinary scientists (including health economics and outcomes research, medical affairs, clinical development and others), company affiliates project leads and Late Development Statisticians in long-range project planning and statistical guidance in support of HTA projects
  • Interacts with Academic Research Organizations, Contract Research Organizations and external statistical consultants

Primary activities for the position:

  • Performs managerial and administrative duties including coaching, performance management and expense report approval consistent with grant of authority
  • Directs recruiting efforts to hire qualified statisticians
  • Directs the scientific and technical development of statisticians. Encourages staff to conduct research and publish/present scientific findings and methodologies
  • Coordinates statistical project assignments and resource allocation in collaboration with other managers
  • Contributes to the definition of the HTA strategies and promotes sound and up to date statistical methodologies
  • Is involved in research activities for innovative statistical methods and applications in HTA activities
  • Provides effective and efficient statistical oversight and ensures consistency of methodological approaches for HTA projects
  • Represents HTA Statistics in meetings with management and other groups in strategic planning of projects
  • Performs comprehensive review of statistical analysis plans, statistical reports and HTA submission documents to insure accuracy of statistical content
  • Leads the preparation of responses to queries from HTA agencies related to statistical analyses and methodologies. Assesses the statistical rationale

Qualifications

Education and Minimum Requirement:

  • PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or Master`s with a minimum of 12 years relevant work experience.

Required Skills and Experience:

  • Prior supervisory and project management experiences are necessary
  • Excellent oral and written communication skills
  • Record of functioning effectively in a cross-disciplinary, cross-cultural team environment
  • Strong knowledge of biostatistical analysis methodologies and experimental design, including meta-analyses and time to event methodologies. Understanding of data management and clinical concepts applied to drug development within the pharmaceutical industry.
  • Working knowledge of statistical and data processing software e.g. SAS and/or R. Demonstrates strong interest and ability in statistical research activities and in application of novel methods to clinical development.
  • Late stage development experience

Preferred Skills and Experience:

  • A record of relevant publications/presentations, professional service and familiarity with relevant emerging trends in the pharmaceutical industry is desirable
  • Good knowledge of computer systems and clinical databases systems in a statistical environment.
  • Good Connections in the scientific statistical community
  • Understanding of biology of disease and drug development
  • Experience of leading role in drug regulatory/HTA environment

The BARDS organization has established in Europe its Center of Excellence supporting Health Technology Assessment (HTA) dossiers. Our statisticians and statistical programmers collaborate with multiple functional areas across the company and with our local affiliates to ensure that the clinical trial data representing our products is characterized properly in these dossiers, and to develop innovative statistical approaches to novel problems in the HTA space.

The COMPANY

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Weystrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.

Zurich

The recently opened new location in Zurich focuses on accelerating research, data and commercialization of our medicines and vaccines. The new office will be staffed by teams working in strategic and operational roles in medical affairs, clinical development, access and marketing operations functions. The new location has a target date of 2021 for operational readiness.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific.


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