Associate Principal Biostatistician, Clinical

Vor 5 Tagen

Zurich, Schweiz MSD Vollzeit

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 an experienced **Associate Principal Biostatistician, Clinical Safety Statistics **to join the BARDS Team based in our new office in Zürich. (_full-time, indefinite_).

The BARDS organization has established in Europe its Center of Excellence supporting Health Technology Assessment (HTA) dossiers. The BARDS organization is expanding our global presence by establishing clinical safety statistics capabilities in our newly established R&D hub in Zurich, Switzerland.

**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.
- Additional responsibilities, based on business needs, could include providing support to BARDS Late Development Statistics (LDS) projects and / or to HTA submissions beyond safety analyses
- Collaborate with HTA statistics, late development statistics and scientific programming groups to ensure high quality statistical deliverables for submissions to health authorities
- Contribute to the preparation of the written reports to effectively communicate statistical findings in HTA submissions
- Contribute to the design and development of statistical methodologies, processes, standards and tools for clinical safety evaluation
- Support the planning and execution of ongoing safety evaluations across pre-marketing and post-marketing drug development life cycles
- May provide statistical leadership to cross-functional safety teams for strategic planning and scientific reasoning activities that facilitate safety evaluation.
- May mentor and guide junior staff

**QUALIFICATIONS**:

- PhD or equivalent degree in statistics\biostatistics or related discipline with a minimum of 3 years relevant work experience, or master’s with a minimum of 6 years relevant work experience.
- Fluency in English (oral and written).
- Solid knowledge of clinical trial design and statistical analysis methodologies, including survival analysis, meta-analysis and Bayesian analysis.
- Good 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.
- Team oriented, strong collaboration skills and ability to work effectively across cultures
- Good oral and written communication skills; ability to function effectively in a team environment with personnel from different functional areas

**Preferred Skills and Experience**:

- Strong knowledge of computer systems and clinical databases systems in a statistical environment
- Experience in late stage clinical development, including in CDISC data standards (SDTM, ADAM) and / or HTA
- Understanding of biology of disease and overall drug development process

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 Zürich, 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 Zürich focuses on accelerating research, data and commercialization of our medicines and vaccines. The new office is staffed by teams working in strategic and operational roles in medical affairs, clinical development, access and marketing operations functions.

**WHO WE ARE **

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at th

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