Lead complex statistical studies and oversee project management activities while mentoring junior staff. Develop statistical plans and conduct thorough reviews for clinical trials.
As an experienced Principal Biostatistician in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex clinical trials for renowned, innovative and global top pharmaceutical and biotech companies.
In this role you will develop and review Statistical Analysis Plans for data presentation, analyses, and provide programming support to your multidisciplinary global project team.
About the team
You will be part of a long-lasting partnership with one of our top sponsors (a 10-years relationship) for which we pride ourselves on being the preferred provider.
In this team, you will work with over 150 people globally, all with great experience and ready to support you at any given time since we work globally from the US to APAC.
What else can you expect from us?
- Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
- Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
- A genuine work life balance
- Flexibility in working hours
- A thorough onboarding with support from your personal mentor
- Excellent training and career development opportunities, as well as support with advancing your individual education
- Strong support from your Fortrea Line Manager and your team, as well as from more than 19,000 colleagues worldwide
Your responsibilities:
- Lead complex studies such as New Drug Applications submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings
- Perform project management activities for identified projects including resource planning, timelines and milestone management
- Serve as Data Monitoring Committee Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants
- Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians
- Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery
- Review Case Report Form and other study specific specifications and plans
- Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant
- Preparation and review of randomization specifications and generation of randomization schedules
- Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures
- Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences
- Attend bid defense meetings for complex studies
- Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives
- Represent the department during audits.
Your profile:
- Degree in a relevant field such as statistics, computer sciences, etc.
- Solid experience of working as a Lead Biostatistician in either a biotech, CRO or pharmaceutical company
- Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses; SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
- Proven professional experience with SDTMs, ADaM datasets and TFLs
- Proven ability to effectively communicate statistical concepts
- A good knowledge of the overall clinical trial process
- Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials
- Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail
- Business fluency in English – both verbal and written – is a must
Learn more about our EEO & Accommodations request here.
Top Skills
SAS
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