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Associate Director Biostatistics
hace 3 meses
At Premier Research, we help biotech and specialty pharma companies transform life-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.
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.
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 cross-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 stand-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 TMF
- Ability to manage and de-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 work-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 SAS
- Previous 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 out-of-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 fast-paced environment with changing priorities.
- Strong verbal and written communication and negotiation skills.
- Excellent organizational and time-management skills, able prioritize work to meet
