Covance AD Statistics in Shanghai, China
Supervision of less-experienced biostatisticians and of statistical programmers within project activities.
Represent biostatistics supporting company business development, client and regulatory interaction/communications.
Provide statistical expertise consultancy to client regarding clinical drug and protocol development
Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.
Develop and maintain close working relationships with the management of other disciplines, particularly those that interact closely with the department, to ensure consistency in approach, ongoing cooperation and teamwork, and regular discussion regarding process improvements.
Support senior management in all aspects of the management and development of the discipline.
Build an open and communicative environment in which concerns can be raised and where the input of all is evidently valued.
Provide ongoing guidance and mentoring to ensure thorough knowledge of the processes used and ongoing technical development.
Maintain a positive approach, building a motivating and professional team environment.
Facilitate the flow of information, comment and feedback between senior management and all levels of staff.
Ensure appropriate review of deliverables, implementing follow-up activities at the individual or departmental level.
Carry out line management responsibilities for assigned staff, including Performance Management and Development activities, disciplinary procedures and administrative activities.
Work with Training specialists and other disciplines to ensure all members of the department receive training required to fulfill current role or to develop further.
Biostatistics lead for large global or other major programs.
Provide training on biostatistics-related topics to other disciplines.
Provide input to the optimal global utilization of resources in Biostatistics and Statistical Programming based on project requirements, resource availability, efficient utilization, and staff competencies and development needs.
Perform recruitment activities on behalf of the department.
Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
Assume responsibilities for Lead Biostatistician or other statistical role, e.g., DMC biostatistician, for assigned projects. Tasks include, but are not limited to, protocol and CRF input, preparation of Statistical Analysis Plan, responsibility for Biostatistics’ deliverables, analysis, reports, SAS programming.
Develop and coordinate QC procedures for Biostatistics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within a specific project.
Determine documentation requirements for statistical aspects of projects. Give guidance to support business and regulatory requirements including definition of appropriate documentation, storage/communication media, and retention/return of documents at study close-out.
Develop procedures for establishment and support of special committees, e.g., DMC, IRC.
Advise on statistical aspects of submissions to regulatory authorities; participate in presentations to regulatory reviewers.
Supervise SAS programming and related activities for the presentation and analysis of clinical trial data.
Identify opportunities to interact with other operational areas to further the delivery of quality and timely products by Covance.
Proactively lead, review and amend departmental processes and documentation.
Drive new initiatives including process improvements within Covance.
Act as statistical consultant for clients and Covance staff.
Represent Covance as primary technical contact on projects and in the development of contracts. Interact with senior client personnel in negotiation and coordination.
Provide input and review of new business proposals, including time and cost estimates and associated documentation; participate in associated client development activities.
Represent department during audits, particularly those related to new client opportunities.
Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP.
Perform other duties as requested by management.
MA or MS in statistics subject, preferably with a strong medical statistics component. (Alternative academic qualifications are assessed for comparability.)
Twelve years of postgraduate experience in the application of statistics to clinical trials, preferably with at least 2 years of statistical project responsibility with a CRO.
A broad up-to-date knowledge of statistics as applied in clinical trials across therapeutic areas.
SAS proficiency including use of a variety of statistical procedures, e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis.
Competence in ensuring Statistical Analysis Plans, analysis, reports, etc., are produced efficiently and to a high quality by less experienced biostatisticians.
A strong ability to explain statistical concepts to non-statisticians.
Full knowledge of the interactions required by a biostatistician throughout the lifespan of a trial; a substantial knowledge of the responsibilities of those departments with whom biostatisticians and statistical programmers interact.
A substantial knowledge of the overall clinical trial process and of its application within Covance Clinical Development.
Knowledge of the metrics, tools and processes used within Covance to manage projects.
Interpersonal and effective communication skills; able to communicate appropriately throughout Covance and with its clients.
Strong supervisory skills, and the ability to organize their own and others’ work.
Strong delegation skills.
Excellent problem solving skills and a willingness to take ownership of decision-making.
Evident application of past experience.
Cooperative, team-oriented and proactive.
Self-motivation and self-reliance.
Ability to motivate others.
An awareness of the factors influencing Covance Clinical Development’s business needs.
A proactive approach to the management of day-to-day activities and actions that may affect Covance as a business.
The ability to plan and to adapt to changing situations.
A professional approach at all times.
Job Number 2018-21637
Job Category Other
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.