Principal Biostatistician, Clinical Safety Statistics (m, f, d)
MSD
Regus, Zurich, Switzerland
vor 6 Tg.

Job Description

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.

We are currently looking for a Team of experienced Principal Biostatistician, Clinical Safety Statistics to join the department of Biostatistics and Research Decision Sciences (BARDS) Team based in our new office in Zürich.

You will be part of the BARDS organization which has a presence in the US, EU 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 drugs and vaccines making a real difference in patient’s lives.

Since its establishment in 1938, the BARDS department has provided over 80 years of quantitative leadership in the innovation and application of research design and statistical analysis methods 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.

The BARDS organization is expanding our global presence by establishing clinical safety statistics capabilities in our newly established R&D hub in Zurich.

Clinical Safety Statisticians play essential roles in drug safety evaluation and its submission to health authorities, including safety analyses and submissions to HTA authorities.

THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO :

  • Lead, coordinate or provide statistical support to projects in the BARDS Clinical Safety Statistics (CSS) group, focusing on safety analyses supporting HTA submissions.
  • Lead or contribute to the design and development of statistical methodologies, processes, standards and tools for clinical safety evaluation.
  • Lead the collaboration with HTA statistics, late development statistics and scientific programming groups to ensure high quality statistical deliverables for submissions to health authorities.
  • Take a lead role in the preparation of the written reports to effectively communicate statistical finding in HTA submissions.
  • Lead the planning and execution of ongoing safety evaluations across pre-marketing and post-marketing drug development life cycles.
  • Provide statistical leadership to cross-functional safety teams for strategic planning and scientific reasoning activities that facilitate safety evaluation.
  • May serve as a statistical representative and core member of Risk Management Safety Teams.

  • Mentor and guide junior staff.
  • Involve in research activities for innovative statistical methods and applications in clinical safety evaluation.
  • Play an active role in regional and global biostatistics communities to better enable and promote quantitative safety evaluation throughout product development life cycle and health technical assessment.
  • QUALIFICATIONS :

  • PhD or equivalent degree in statistics / biostatistics or related discipline with a minimum of 6 years relevant work experience, or master’s with a minimum of 9 years relevant work experience.
  • Fluency in English (oral and written).
  • Expert knowledge of clinical trial design and statistical analysis methodologies, including survival analysis, meta-analysis and / or Bayesian analysis.
  • Solid understanding of data management and clinical concepts applied to drug development within the pharmaceutical industry.
  • Solid knowledge of statistical and data processing software e.g. SAS and / or R. Familiarity with Visual Analytical Software (e.g., R*Shinny) a plus.
  • Good understanding of worldwide regulatory requirements and clinical trial expertise from phase I to V.
  • Demonstrates strong interest in statistical research activities and application of novel methods to clinical development.
  • Good oral and written communication skills; ability to function effectively in a team environment with members from different functional areas and different cultures.
  • Strong project leadership skills.
  • Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs.

    We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.

    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.

    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.

    INSPIRE.

    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 for the common good.

    We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

    BARDSZH2020

    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. Please, no phone calls or emails.

    Employee Status : Regular

    Relocation :

    Domestic / International

    VISA Sponsorship :

    Travel Requirements :

    Flexible Work Arrangements :

    Shift : Not Indicated

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    Valid Driving License :

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