A Senior Biostatistician job position has opened up at an international contract research organisation providing drug discovery, lifecycle management and laboratory services. With offices in over 45 countries and approximately 13,000 professionals, this company provide innovative ideas behind multiple sectors. This particular position will be based in London, UK. The Senior Bio statistician performs management functions relating to the administrative and scientific activities of team members across multiple complex projects. Provides senior-level oversight of statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians. Functions as Biostatistics Project Leader for multiple complex protocols, projects, or NDA projects, including coordinating with other internal divisions and interacting with the client and regulatory agencies.
- Becomes familiar with the activities outlined in the department's Working Practice Documents and contribute changes as needed. Learns and follows departmental procedures for statistical analyses and programming work.
- Serves as a lead statistician across challenging projects; provides Senior Review on projects
- Leads team members across multiple complex projects.
- Reviews sample size calculations and protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections.
- Provides review/analyses on randomization schemes and documentation.
- Reviews specifications for analysis database, oversees its development, and assures completeness for use in all programming. Oversees collaboration with programmers and data management personnel as to database maintenance, updating, and documentation.
- Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis.
- Supervises creation of table and listing specifications. Ensures that proper validation for statistical tables and listings is being implemented.
- Reviews statistical analysis for key efficacy endpoints.
- Prepares reports, manuscripts, and other documents. Contributes statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.
- Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.
- Understands project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope.
- Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management.
- Provides statistical consultancy.
- Mentors members of the department by providing project guidance and statistical advice and by promoting employee development, completing performance planning, and providing resource planning.
- Acts as the representative of the department to other divisions
- Provides input to the Directors, Associate Directors, and Managers as to hiring recommendations, department policies, and resourcing requirements.
- Assists in bidding and business development activities. Consults with business development with respect to bids and timelines.
Skills and Requirements:
- MS/MA degree in statistics, biostatistics, mathematics or related field and 5 years’ experience required; or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills and abilities
- Strong SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH)
- Ability to direct and promote teamwork in a multi-disciplinary team setting
- Ability to review current processes and identify potential process improvements
- Experience of a wide variety of clinical trials/designs and corresponding reporting of data
- Experience in interpreting the results from statistical analyses of complex data
- Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments
- Proven management skills, as shown through management of multiple projects and/or staff members
- Demonstrated initiative and motivation
- Excellent written and verbal communications skills
- Good organizational skills with the ability to adapt and adjust to changing priorities
- Positive attitude and the ability to work well with others
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.