Manager, Biostatistics (US Based)
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. We’re looking for a talented and energetic --JOB TITLE -- to join our team! Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
The Manager, Biostatistics serves as a core team member and leader for larger projects and works in a supervisory capacity, coaching the technical evolution of the work product and reviews client deliverables for compliance with project specifications. In this role, the individual is responsible for both management and technical aspects of development projects. As a technical expert, he/she provides statistical oversight to Sponsor projects with particular emphasis on meeting timelines, keeping budgets on track, and ensuring quality deliverables. The Manager, Biostatistics provides guidance, coaching and development to more junior staff while overseeing the technical evolution of the department work product.
The Manager, Biostatistics contributes at least 60% of their time to Biostatistics project work at the Senior Principal Biostatistician level of technical expertise and experience. He/she serves as a Project Manager on stand-alone work, ensuring that project teams adhere to Premier Research’s Standard Operating Procedures and project-specific guidelines. The Manager also assists with audits when requested, and reviews departmental deliverables for accuracy, completeness, and compliance with project specifications.
The Manager, Biostatistics:
- Independently develops SAS programs to generate listings, tables and figures as outlined by a statistical analysis plan and to generate randomization codes
- Performs QC of TLFs, CDISC and other analysis data sets
- Prepares specifications for CDISC and other analysis data sets
- Independently develops statistical analysis plans
- Acts as Lead Biostatistician to interact with the study team and the Sponsor
- Supports Business Development by preparing for and attending bid defense meetings, preparing capabilities presentations, and assisting with budget and proposal development.
- Acts as an independent Biostatistician on DSMBs and DMCs
- Acts as Project Manager for one Biostatistics stand-alone project, and completes consultancy work as needed
- Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop the team structure
- For project success:
- Develops and maintains overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
- Keeps detailed records of time spent on each project to allow accurate billing
- Respects and maintains the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with
- Maintains Biostatistical section of TMF
- Reviews and provides feedback on Data Management documents
- Reviews study protocols
- Provides statistical input to Clinical Trial Reports
- Facilitates resolution of project related conflicts with necessary corrective action and alerts senior management to potential issues
- Develops strong relationships with current clients to generate new and/or add-on business for the future
- For commercial success:
- Ensures work completed is completed is on time at the correct level of quality
- Builds strong relationships with Data Management to provide proactive support
- Tracks project revenue and backlog
- Tracks hours by keeping detailed records of hours worked on projects for accurate billing and to forecast hours to complete
- Ensures that audits have appropriate Biostatistics representation and participates as necessary
- Participates in and contributes to the training and development of new Biostatisticians
- Participates in efforts for efficiency and productivity in the department
- Attends project team and other company meetings, as required
- Participate in corporate initiatives and actions that ensure the continued success of the company
- Performs other work-related duties as assigned
EDUCATION, SKILLS & COMPETENCIES:
- Educational Background
- Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field
- 6– 8 years of experience in clinical trials design and analysis using SAS
- 0 – 2 years of 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.)
- Expertise and know-how
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook Evidence of good SAS programming skills
- Knowledge of web based communication tools for conferences
- Evidence of advanced SAS programming skills
- Applies clear and consistent performance standards and handles problems decisively and objectively
- Personal skills & behaviours
- 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 deadlines.
- Accountable, dependable and strong commitment.
- Is customer service focused in approach to work both internally and externally.
- Maintains a positive, results orientated work environment.
- Ability to build client confidence and achieving high levels of customer satisfaction
- Ability to communicate basic statistical concepts to other scientists and nonscientists
- Ability to motivate and lead a team of varying levels of status and ability
- Proactive management skills
- Cross cultural awareness
- A willingness to travel, ~20%