Director, Biostatistics (US Based)
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Analgesia, Neuroscience, Oncology, Dermatology, Pediatrics, and Rare Diseases.
We’re looking for a talented and energetic Director of Biostatistics to join our team! This is a very exciting opportunity to join a dynamic and innovative team and grow with a forward-thinking organization that is changing to course of medicine.
Working at Premier Research means being an individual - you will be recognized 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!
As the Director of Biostatistics, you’ll have the opportunity to serve as a core leader for critical and innovative projects. You will oversee and provide strategic guidance for Biostatistical operations, project assignments, and the overall activities of a collaborative and stable project team for both a management and technical aspect (with particular emphasis on scientific rigor and application of ‘current’ statistical methodology). You’ll also ensure quality deliverables to the sponsor as well as compliance with project specifications. As the Director, you will also provide coaching guidance and management to the team in addition to overseeing the technical evolution of the departmental work product.
You will have the opportunity to represent the department during bid meetings, audits, and for statistical advice throughout clinical projects.
What you’ll be doing:
- Supervise, mentor, and motivate reporting team members in tasks and activities that aligns with Premier’s aspiring, empowering and high performance culture and assigns work to team
- Act as Lead Biostatistician to interact with the study team and the Sponsor and Project Manager for stand-alone projects, consultancy work, DSMBs and DMCs
- Support Business Development by preparing for and attending bid defense meetings, preparing capabilities presentations, and assisting with budget and proposal development.
- Direct efforts in Biostatistics project costing estimates and change order process; provide oversight and reporting of project progress and financial health within Biostatistics; track project revenue and backlog as well as hours for accurate billing and to forecast hours to complete
- Participate in functional and/or corporate initiatives, including committees, special assignments, and act as the departmental cross-functional liaison
- Develop and implements strategies to actualize goals; develop and maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
- Represent Biostatistics as Statistical expert both internally and externally
- Facilitate resolution of project related conflicts with necessary corrective action and alerts senior management to potential issues
- Prepare specifications for CDISC and other analysis data sets
- Independently develop statistical analysis plans and SAS programs to generate listings, tables and figures as outlined by a statistical analysis plan and to generate randomization codes
- Maintain Biostatistical section of TMF
- Perform QC of TLFs, CDISC and other analysis data sets
You’ll need this to be considered:
- Advanced degree (MS or PhD) in statistics or closely related field along with 8 years of experience in clinical trials design and analysis using SAS, including 4 years of experience as supervisor/manager
- Knowledge of ICH, local regulatory authority drug research and development regulations along with demonstrated experience in interactions with regulatory agencies (FDA, EMA, EU member states)
- Proven experience of advanced SAS programming skills; prior experience using computerized information systems; proficiency in Microsoft Office; knowledge of web based communication tools for conferences
- Proven to apply clear and consistent performance standards and handles problems decisively and objectively
- Known to build client confidence and achieving high levels of customer satisfaction
- Ability to communicate basic statistical concepts to other scientists and nonscientists
- Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites, clients, vendors and other functional areas; strong verbal and written communication and negotiation skills
- Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team; Strong people management skills to motivate, enthuse, and lead
- Excellent organizational and time-management skills, able prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment.