Statistician-Near Radnor, PA
As a biostatistician, you will be responsible for preparing Statistical Analysis Plans, performing and interpreting statistical analyses and writing statistical sections of study reports. You will be performing analyses on unblinded pharmacodynamic clinical trial data, as well as analyzing data in blinded fashion looking for aberrant patterns and sources of noise. You will be collaborating with lead scientists on research activities, presenting outcomes of your analyses for prestigious scientific conferences or in peer reviewed scientific journals.
Responsibilities:
- Conducts statistical analyses using SAS, Stata or relevant statistical program
- Provides statistical support for clinical studies and Develops programming code (SAS, Stata, etc.)
- Writes code and conducts QC checks of code and output files according to current SOPs, templates and guidance documents
- Merge randomization code to final locked dataset for use in analysis as required
- Produces sponsor specific formatting for datasets and output as required
Requirements:
- Bachelor’s Degree in statistics or other numerate subject
- SAS Programming Experience (e.g., Base SAS, SAS Stat, SAS Graph)
- Experience using SAS Proc Report, SAS Proc Mixed, SAS Macro and SAS Proc SQL preferred
- Experience Conducting Statistical Analysis and Writing Statistical Analysis Plans
- Experience analyzing clinical trial data
Please email resume to Jeff@scientificsearch.com
Director of Quantitative Methods-Near Cranbury, NJ
Director of Quantitative Methods contributes to the organization in a range of arenas, which include but may not be limited to the following:
- Organizational Direction: Works with President to set direction for the organization from the perspective of future business trends/challenges, its evolving research offerings and how these offerings are communicated to customers.
- Problem Definition: Uses topical knowledge of healthcare industry and healthcare market research to anticipate industry trends and challenges, and provides direction to the organization to anticipate and respond accordingly.
- Methods Consulting: Serve as a senior methodological and content consultant to project teams encountering specialized problems; identifies and manages resources to support project teams with specific research challenges.
- Skills Dissemination: Responsible for training staff on advanced quantitative methodologies and contributing to training and on-boarding materials and process generally.
- Business Development: Contribute to the sales process both through generation of personal business (e.g., through prior relationships) and through assisting business development professionals in learning and communicating key features of specialized methods, including BioVid’s proprietary methodologies and tools.
- Industry Positioning: Industry facing presence at major meetings, such as PMRG and PBIRG, including regular presentations on BioVid methodologies.
On a day-to-day basis the Director of Quantitative Methods is involved in the following types of activities:
- Direct methodological consultation with clients/project teams to solve real-time research problems.
- Proposal development support to business development team, including generation of client-ready conceptual and methodological slides for proposals.
- New product development and consultation with the President on the promotion of new product offerings.
- Work in close collaboration with Director of Qualitative Methodologies to develop, define and provide integrated offerings.
- Individual and group-based training of staff on specific methodological skills. Note that observable improvement in staff technical skills is a major performance criterion for this role, and will play a key role in year-one evaluation.
Email Michellel@scientificsearch.com for immediate consideration
Clinical Trial Manager
The Clinical Trial Manager will report to the Vice President – Clinical Development, Quality Assurance & Regulatory Affairs. The responsibility of the Clinical Trial Manager will provide operational, and compliance support to the Clinical Development Programs. This is initially a temporary position, and depending on the candidate’s performance, as well as an ongoing workload, there is a possibility it may become a full time direct position.
Our client is focused on the development and commercialization of innovative therapeutic products which utilize its proprietary technology. Their technology has been used in two approved products, and is being used in several other products in clinical development. The company has a robust pipeline with several late stage pain and inflammation candidates which have been partnered and a number of in-house clinical assets.
Responsibilities
- Selecting potential external vendors for clinical services and coordinating with QA consultant/manager to qualify external vendors to provide clinical and manufacturing services.
- Working with internal personnel and managing and supporting external CRO partners in the design, conduct, data analysis and reporting of phases 1 through 4 studies; specific responsibilities not limited to: providing input into protocol and protocol-related documents; site monitoring plans; eCRP completion guidelines; data analysis and validation plan; IVRS/IWRS system programming; computer validation checks; coordinating and actively participating in reviews of tables and listings to support the achievement of study milestones and sign-off of additional in process documents.
- Interfacing with internal personnel and external vendors to coordinate timing of clinical trial conduct with availability of manufactured and labeled Clinical Trial supplies, including comparators.
- Preparation of clinical protocols and Case Report Forms.
- Finalization of monitoring and data management options (either in-house or contracted).
Requirements
- BA/BS degree or equivalent; science or healthcare preferred.
- At least 8 years of experience in pharmaceutical/biotechnology at least 5 years of experience in clinical development which may include experience in clinical pharmacology, clinical operations, clinical project management, clinical compliance and/or medical writing. Experience as a clinical trials manager is required. Direct experience managing clinical data or biostatistics is valuable but not required.
- Experience managing external vendors of clinical services is required.
- Experience in and thorough understanding of ICH GCP is required.
For immediate consideration please email resume as a Word attachment to Tom Terrill, TomT@scientificsearch.com
