Statistical Scientist (f/m/d)

Statistical Scientist (f/m/d) – clinical trial data / SAS or R / drug development / Communication and Collaboration / Project management / English

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Statistical Scientist.

Background:
Personalized healthcare (PHC) means better health, at a lower cost, for people and society. It means shifting from a one-size-fits-all approach to the best care for each person. The convergence of pioneering science, data, analytics and technology-existing and new-is central to this vision. Floodlight™ MS is a science-based smartphone app that enables data-driven clinical conversations and healthcare provider decisions by providing assessments that can be used to collect objective data on patient function in-between clinical visits. The assessments measure gait and dynamic balance, hand function, and cognitive function. The app also provides questions that enable users to journal MS symptoms, mood, and physical status. This data in combination with the in-person physician visits provide a more complete picture that allows better and more accurate healthcare decisions. Floodlight™ MS is available in select healthcare clinics or through app partners in selected markets. These include the United States, Germany, Finland, and Portugal, and availability will expand across additional markets in 2023. It is accessible as a standalone application and also offers options to enable interoperability with third party solutions. The Floodlight project aims at developing a Software as Medical Device (SaMD), product called Floodlight, used to detect changes in motor function and cognition in patients with Multiple Sclerosis, using sensors from customer-grade devices (phone). In particular, the Floodlight intent to cover three functional domains: -Cognitive domain: -Hand function -Gait function Floodlight is intended to improve the management of Multiple Sclerosis(MS) in clinical practice to achieve better clinical outcomes for patients living with MS (plwMS) and reduce cost for the society. The project requires support in the clinical validation of the SaMD. In order to achieve this, clinical studies and observational studies are currently ongoing, where the patients are using Floodlight. These studies require study statistics support, and interface with the data science teams working on the development of the smartphone App SaMD. You will be part of the PDD Floodlight Data Science team which has many interactions with other departments for example; with pREDi and Diagnostics. Firstly data management handles the ingestion of the digital and clinical data from the raw digital data to the derived features, statistical
programming and data engineering of the digital variables and creation of analyses-ready datasets as well as trials LoPos, and statistical science aspects of clinical validation.

The perfect candidate: A statistician with more than 3 years of experience as a clinical study statistician, with a MSc/PhD in statistics or data science related fields, with good collaboration skills and communication skills, willing to learn and develop in health care areas such as the development of a digital health technology-based software as a medical device.

Tasks & Responsibilities:
*Clinical Study and observational study Planning: in collaboration with Senior Statistical Data Scientists, reviews study protocols, authors statistical sections of protocols.
* In collaboration with Senior Statistical Scientists, develops independent data monitoring and endpoint committee charters.
* Development of the statistical and data analysis plans, and preparation of the study randomization.
* Study Conduct: reviews case report forms to ensure protocol objectives are met and project standards are maintained;
* Development of statistical programs as necessary to perform analyses, review analyses produced by statistical programming, ensuring the accuracy & validity of results.
* Clinical/observational study Analysis & Reporting: author the clinical study report, In collaboration with Senior Statistical Scientists and cross-functional team members, provides input into global health authority documents and regulatory response for health authority submissions

Must Haves:
* MSc or PhD in Statistics, Biostatistics, Mathematics or similar areas of academic discipline.
* Minimum of 3 years of experience as a clinical study statistician.
* Experience in Running, planning and interpreting clinical trial data .
* 3 years of Experience in using statistical software SAS or R.
* Good knowledge of theoretical and applied statistics.
* Knowledge and experience applying statistical methods to drug development. Understanding of regulatory guidelines in a pharmaceutical research setting. Understanding and application of business requirements and processes.
* Understanding and respecting cultural differences when interacting with colleagues globally. Accomplishes responsibilities with supervision.
* Good Communication and Collaboration Skills (including statistical consulting skills, interpersonal skills to contribute effectively in cross-functional team settings, ability to influence
others without authority, ability to build strong collaborative relationships with scientific and non-scientific partners).
* Evident Drive for Results (Demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges; finds solutions to technical problems).
* Good knowledge of English in a business environment.
* Leadership: Leads coordinated, thoughtful, fit-for-purpose solutions for projects/initiatives; Facilitates and influences teams and individuals to advance the business to achieve work packages and outcomes

Nice to Haves:
* Project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors).
* Strategic Agility (including problem-solving and critical thinking skills, ability to drive drug development strategies, agility that extends beyond statistical aspects).
* Prior experience with SaMD Launch preferable but not mandatory

Reference Nr.: 922586SDA
Role: Statistical Scientist
Industrie: Pharma
Workplace: Basel
Pensum: 100%
Start: 01.06.2023
Duration: 12++
Deadline: 02.05.2023

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.