Associate Director Biostatistics Bucharest

Associate Director Biostatistics

Romania

At Premier Research, we help biotech and specialty pharma companies transform
- changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2, 000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today. We’re looking for a Associate Director Biostatistics join our Biostatistics team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building
- functional partnerships that enable your growth and success. What you’ll be doing:Participates and contributes to the training and development of new biostatisticians
Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop the team structure
Peer reviews draft statistical analysis plans and provides feedback
Acts as Lead Biostatistician to interact with the study team and the sponsor
Independently develops statistical analysis plans
Performs QC of TLFs, CDISC and other analysis data sets
Prepares specifications for CDISC and other analysis data sets
Presents biostatistical capabilities in bid defense meetings
Acts as an independent biostatistician on DSMBs and DMCs
Acts as project manager for biostatistics
- alone work
Independently develops SAS programs to generate randomization codes
Strategic responsibility for all staffing and operational aspects of the allocated Biostatistics group
Supervises SAS programming and program validation for a project
Leads efforts in the development, maintenance and adherence to departmental SOPs and guidelines
Develops and implements strategies to actualize goals
Ability to lead process improvement efforts
Keep detailed records of time spent on each project to allow accurate billing
Maintain biostatistical section of TMFAbility to manage and
- escalate difficult situations with clients, teams, and management
Ability to motivate and lead a team of varying levels of status and ability
Attend project team meetings as required
Capability and willingness to coach and mentor others
Demonstrated critical thinking with a history of bringing forward strategic initiatives
Develop and maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc. Supports Business Development concerning budget and proposal development
Directs efforts in Biostatistics project costing estimates and change order process
Ensures that audits have appropriate Biostatistics representation
Perform other
- related duties as assigned
Provides consultancy to sponsors on statistical issues
Provides oversight and reporting of project progress and financial health within Biostatistics
Provides statistical input to Clinical Trial Reports
Respect and maintain the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with
Review data management documents
Supports Business Development by preparing for and attending bid defense meetings
Tracks hours worked on projects and forecasts hours to complete
Tracks project revenue and backlog
What we are searching for: Previous experience in clinical trials design and analysis using SASPrevious experience as supervisor/manager
Prior experience using computerized information systems preferred. Ability to read, write, and speak fluent English
fluent in host country language. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Works with internal and external customers/vendors to meet project specific goals. Identifies, monitors, documents, and tracks
-
- scope activities. Demonstrated experience in interactions with regulatory agencies (e. g. , FDA, EMA, EU member states, etc. )Fluent verbal, written, and interpersonal English as well as the local language(s) required for clinical trial submissions. Excellent team player, collaborative and able to build an effective team. Ability to multitask and work effectively in a
- paced environment with changing priorities. Strong verbal and written communication and negotiation skills. Excellent organizational and
- management skills, able prioritize work to meet deadlines. Accountable, dependable and strong commitment
Why choose Premier Research?  Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.  Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful. Because we are transforming
- changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging thatwelcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others. Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines.  All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.  #LI-KT1