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.
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.
We are currently looking for an Associate Director Statistical Programming, Health Technology Assessment to join a dynamic international team as of March 2021 on a position based in our new office in Zürich. (full-time, indefinite).
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.
This position supports statistical programming activities focusing on the analysis and reporting needs for Health Technology Assessment (HTA) dossiers. From this position the associate director has a dual leadership role with both management and direct project contributions (at project lead role). In collaboration with the HTA statistical programming leadership team, you will be responsible for implementing departmental objectives and managing projects’ portfolio, resource and operational challenges. In this role, the associate director manages programmers responsible for statistical programming analysis and reporting activities in support of HTA dossiers across multiple therapeutic areas of drug/vaccine clinical development projects.
The position ensures appropriate and consistent application of SOPs, standards and quality and compliance measures. The associate director provides technical and/or scientific guidance to employees and colleagues and contributes to fostering group capability for the delivery of expertise and behaviors required to deliver success on projects.
As a project lead and direct project contributor, the associate director, supports the development of scientifically based arguments aiming to provide fair accessibility to our company’s drugs and vaccines making a real difference in patient’s lives. The position contributes to the definition and implementation of strategic solutions utilizing SAS to create analysis datasets, tables, listing and figures from clinical trial data and is a key collaborator with HTA statisticians and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables. For assigned projects, the position serves as the statistical programming point of contact and knowledge holder.
THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:
Directly contribute to projects and manage staff to programmatically develop, validate, execute and maintain analysis and reporting deliverables for HTA dossiers; contribute to the development of analysis and reporting standards for HTA dossiers
For HTA projects and in collaboration with the HTA statistical programming Leadership Team, the incumbent is responsible for staff resource management including resource allocation and forecasting.
Assure deliverable quality and compliance with departmental SOPs and good programming practices
Collaborate with the Statistical Programming (SP) HTA leadership team, SP project leads, HTA statistics project leads and other relevant stakeholders in ensuring that project plans are defined and executed efficiently with timely and high-quality deliverables.
Leadership and/or membership on departmental strategic initiative teams with strong interest in statistical programming standardization (standards library).
QUALIFICATIONS:
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related analytical field plus 7 or more years SAS programming experience or BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related analytical field plus 9-12 years SAS programming experience.
Fluency in English (oral and written).
Broad knowledge and demonstrated experience in developing analysis and reporting statistical deliverables for R&D projects (data, analyses, tables, graphics, listings) using global and HTA standards according to quality, compliance and timeliness requirements.
Experience managing a team of statistical programmers in the development and execution of statistical analysis and reporting deliverables across multiple therapeutic areas including experience in forecasting programming resources at the project and across-project levels.
Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates new projects and stakeholders; ability to engage key stakeholders.
Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.
Experience in supporting analysis and reporting deliverables for HTA dossiers at a leadership level.
Good understanding of statistics, clinical and data management concepts as applied to drug/vaccine development within the pharmaceutical industry.
Ability to comprehend analysis plans which may describe HTA research and statistical programming methodology to be programmed; an understanding of statistical terminology and concepts.
Knowledge in CDISC SDTM and ADaM standards.
Designs and develops complex programming algorithms.
Experience ensuring process compliance and deliverable quality.
Knowledge of regulatory/HTA agency requirements pertaining to statistical computing and programming issues.
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 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 …
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 the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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.
INVENT.
IMPACT.
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:
RegularRelocation:
Domestic/InternationalVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
Flex TimeShift:
Valid Driving License:
NoHazardous Material(s):
Number of Openings:
1Requisition ID:R77544