Principal Scientist, Biostatistics

Job Description

An opportunity has arisen for a Principal Biostatistician, HTA Statistics to join our team.

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 Biostatistics and Research Decision Sciences (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 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.

We are currently looking for a Principal Biostatistician, HTA Statistics (full-time, indefinite) to join the team based in our office in Zurich (Switzerland).

The HTA Statistics group in the BARDS organization is primarily based in Europe with presence in Brussels (Belgium), London (United Kingdom) and Zürich (Switzerland) and recently also expanding to US (Upper Gwynedd). The primary purpose of BARDS HTA Statistics is to provide statistical solutions to HTA problems, and design and execute statistical analyses of our clinical trial data for HTA submissions. Our statisticians 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.

Responibilities include, but are not limited to:

Bring energy, knowledge, innovation to carry out the following:

- Provides statistical leadership and support to projects in the BARDS HTA Statistics group, including HTA submissions;
- Interacts with multidisciplinary scientists, company subsidiary project leads and Late Development Statisticians to support HTA submissions;
- Designs, develops and evaluates tools and methods for HTA evaluations;
- Gives input to V&I (Value and Implementation) teams as a statistical representative;
- Leads and provides statistical support to the cross-functional teams preparing HTA submissions;
- Plans and executes independently on the ongoing HTA evaluations, including analysis and interpretation of HTA results. Ensure that project deliverables meet analysis and submission requirements;
- Collaborates with Statistical Programming lead to implement methodologies and ensure high quality deliverables for HTA submissions;
- Leads the preparation of the written reports to effectively communicate results of HTA evaluations to cross-functional stakeholders (market access, medical affairs, health economics, outcomes research) and our company’s subsidiary teams;
- Designs, develops and applies HTA methods, processes and standard tools
- Provides responses for queries from HTA agencies related to statistical analyses and methodological rationale;
- Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology;
- Leads research activities for innovative statistical methods and applications in HTA activities;
- Guides and coaches all team members and contractors in functional activities within a project;
- May have line management and coaches direct reports (up to 20% of role)
- Responsible for the performance and results of the department;
- Contributes to building and fostering group capability for the delivery of expertise, exhibiting strong knowledge of the company’s Enterprise Leadership Skills behaviors;
- Manages employee development, performance and participates in all related global company processes
- Works closely with leadership team and other people managers on strategic alignment of team development as well as administrative processes;
- Acts as key point of contact for direct reports in terms of their wellbeing, development and growth.

Qualifications:
Education and Minimum Requirements:

Ph D or equivalent degree in statistics/biostatistics or a related discipline with a minimum of 6 years relevant work experience, or Master’s with a minimum of 9 years relevant work experience, or bachelor’s with at least 15 years relevant experience.

Required Experiences and Skills:

- Good knowledge of biostatistical 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 in statistical research activities and in application of novel methods to clinical development;
- Team oriented, strong collaboration skills and ability to work effectively across cultures;
- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution;
- Project management proficiency;
- Strong communication skills, ability to work with employees with different functional background;
- Strong knowledge of computer systems and clinical databases systems in a statistical environment;
- Experience in CDISC data standards (SDTM, ADAM);
- Understanding of biology of disease and drug development;
- Publication record in peer reviewed statistical/medical journals;
- Experience in managing teams and performance management;
- Effective communication skills and ability to develop people and teams while linking individual development goals to the purpose of the organization.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid
Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
11/28/2024

- A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R323059