Principal Biostatistician - FSP

Principal Biostatistician 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 teamYou 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 companyHighly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.A genuine work life balanceFlexibility in working hoursA thorough onboarding with support from your personal mentorExcellent training and career development opportunities, as well as support with advancing your individual educationStrong support from your Fortrea Line Manager and your team, as well as from more than 19,000 colleagues worldwideYour 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 meetingsPerform project management activities for identified projects including resource planning, timelines and milestone managementServe as Data Monitoring Committee Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical ConsultantsLead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticiansConduct overall statistical review of Tables Figures and Listings for complex studies prior to client deliveryReview Case Report Form and other study specific specifications and plansDevelop the statistical sections of the protocol for complex studies under the supervision of a statistical consultantPreparation and review of randomization specifications and generation of randomization schedulesProvide 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 proceduresPresent and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferencesAttend bid defense meetings for complex studiesAct as Subject Matter Expert and develop or review procedural documents, or work on new initiativesRepresent 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 companyAbility 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 analysisProven professional experience with SDTMs, ADaM datasets and TFLsProven ability to effectively communicate statistical conceptsA good knowledge of the overall clinical trial processCompetence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trialsStrong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detailBusiness fluency in English – both verbal and written – is a mustPay Range: $115,000-$130,000 USD (The range does not include benefits, and if applicable, bonus, commission, or equity)Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), and Company bonus where applicable.