| Company: | Ferring Pharmaceuticals, Inc.
Parsippany, NJ |
| Job Location: |
Parsippany - Morris County
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| Employment Type: | Full Time |
| Department: | FIPCUS (Clinical R&D) |
Description: |
SUMMARY:
FIPCUS is looking for a highly motivated and experienced statistician to support the growing U.S. clinical development organization. The statistician will report to the President FIPCUS/SVP Clinical R & D with dotted line reporting into the Director, of Biostatistics, Global Biometrics (located in Denmark) to ensure a) consistent standards (e.g. SAP templates, definitions of study populations, etc) b) professional interaction and development and c) to facilitate resource sharing.
The position will provide expert strategic statistical support for clinical development programs (phase I – IV) and business development initiatives. This person will also interact with CRO data management, programmers and statisticians to ensure optimal analysis methods and outputs. While responsible for U.S. program support, this person will interact with Global Biostatistics management and colleagues to ensure alignment with corporate processes, policy, and training practices.
This person will work according to the highest standards of current statistical practice in order to ensure acceptable clinical data for U.S. regulatory purposes, planning future clinical research or marketing purposes. He/she will also participate in business development assessments as necessary.
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Duties: |
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The main area of responsibility is to provide statistical support for FIPCUS projects across the various therapeutic areas (reproductive health, urology, gastroenterology, orthopedics) from phase I – IV. This includes:
•Participate in clinical development plan process, including discussion of the program strategy, study designs, selection of endpoints, analysis methods, sample size determination
•Participate in the protocol development process with responsibility of preparing the statistical section and the Statistical Analysis Plan.
•Analyse trial data to extract maximum value and assist in interpretation and communication of results
•Shared responsibility for creation and maintenance global product databases (dynamic repository) in SAS Drug Development (SDD)
•Provide programming and validation support
•Prepare statistical reports and other statistical documentation in support of submissions
•Interact with internal clients to prepare project proposals
•Interact with authorithies regarding submission plans and submission
•Management of outsourcing when necessary
•Participate in departmental tasks (e.g. updating SOPs)
•Provide statistical assessment for selected business development opportunities
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Qualifications: |
QUALIFICATION REQUIREMENTS:
Education and Experience: He/she must have an MSc or PhD qualification in Statistics and at least 5 years relevant experience in the pharmaceutical/CRO industry. He/She must be skilled in applied statistics and are used to participating in the implementation of new statistical methodology / tools. This person must have a sound knowledge of SAS and an understanding of life sciences / medicine.
•Master Degree / PhD in statistics/mathematical statistics,
•At least 5 years experience as a biostatistician in the pharmaceutical industry
•Good knowledge on regulatory statistical guidelines
•Ability to communicate statistical issues to non-statisticians
•Effective problem solving skills
•Innovative, flexible and self-starter
•Good scientific reporting
•Good working knowledge of SAS
•Fluency in English
Personal Attributes: Strong strategic and communication skills are essential in this role which has interactions with many other disciplines. You have the ability to work independently and as part of a project team; you have strong analytical, problem-solving and organisational skills. The successful candidate will be a strategically oriented biostatistician with ability to draw on strong technical statistical skills to successfully bring new products to the U.S. market. He/she must be a good team-player and be motivated, well organised, friendly and keen on working in a multicultural environment. |
