Director, Biostatistics
Covance Inc. (Central New Jersey, New Jersey)

At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities.
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. There is no better time to join us!

Currently we have an exciting opportunity for a Dir, Biostatistics.

As a Dir, Biostatistics you will:

• Assume responsibilities for Lead Statistician or other statistical role, eg, DSMB statistician, for assigned projects. Tasks include, but are not limited to, protocol and CRF input, preparation of Statistical Analysis Plan, responsibility for Biostatistics’ deliverables, analysis, reporting, SAS programming.
• Develop and coordinate QC procedures for Biometrics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within a specific project.
• Define performance requirements within Biostatistics in terms of competencies, role definitions etc.
• Supervision of less-experienced statisticians within project activities.
• Statistical/Biometrics lead for large global or other major programs.
• Project management activities across multi-project programmes.
• Serve as Project Director when required.
• Participate in management reviews of all departmental project activities.
• Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.
• Ensure the delivery of high quality work to internal and external clients through ongoing quality management, review and implementation of appropriate follow-up activities.
• Ensure the provision of statistical consultancy for clients and Covance staff.
• Provide advice and ongoing review to Covance and its clients on statistical and associated regulatory and business considerations.
• Develop procedures for establishment and support of special committees, eg, DSMB, CEC, IRC.
• Coordinate biostatistical aspects of submissions to regulatory authorities; participate in presentations to regulatory reviewers.
• SAS programming and related activities for the presentation and analysis of clinical trial data.
• Develop and maintain close working relationships with other disciplines, particularly those who interact closely with Biostatistics.
• Represent Covance as primary technical contact on projects and in the development of contracts. Interact with senior client personnel in negotiation and coordination.
• 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.
• Interact with senior leadership across disciplines at a global level.
• Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions on a regular basis and to communicate these clearly.
• 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 fulfil current role or to develop further.
• Encourage open and communicative two-way interactions within the department.
• Provide training on biostatistics-related topics to other disciplines.
• Provide ongoing guidance and mentoring within the department to ensure thorough knowledge of the processes used and ongoing technical development.
• Organise and chair departmental meetings.
• Proactively lead review and amendment of departmental processes and documentation.
• Ensure the provision of support from Biostatistics for preparation and review of TCEs and associated documentation, and for related client development activities.
• Represent Biostatistics in the development and ongoing review of costing models and supporting documentation.
• Represent the department during audits; implement appropriate actions based on feedback from audits, customer satisfaction surveys, and other formal/informal feedback.
• Provide input to the optimal global utilisation of resource in Biostatistics based on project requirements, resource availability, efficient utilisation, and staff competencies and development needs.
• Provide recommendations on, and implementation of, global business strategy for Biostatistics.
• Actively promote business development activities, marketing biostatistical capabilities so as to acquire new business within the strategic plan.
• Identify and participate in the assessment and implementation of new technologies or of new applications for existing ones.
• Maintain awareness of new developments in discipline-related techniques, which may be applied to the management and reporting of clinical trial data.
• Drive new initiatives including process improvements within Covance.
• Provide input to HR to aid the recruitment and retention of appropriate staff.
• Deputise for the Director of Operations as required.
• 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.

Experience:

• Approximately 10 years’ postgraduate experience in the application of statistics to clinical trials, preferably with at least three years of statistical project responsibility within a CRO.
• An expert and up-to-date knowledge of statistics as applied in clinical trials across therapeutic areas.
• At least five years’ line management experience for those in a line management role.
• SAS proficiency including use of a variety of statistical procedures eg, non-parametric analysis, linear and non-linear models, categorical data and survival analysis.
• The ability to guide others so as to ensure Statistical Analysis Plans, analysis, reports etc are produced efficiently and to a high quality by less-experienced statisticians.
• A strong ability to explain statistical concepts to non-statisticians.
• Full knowledge of the interactions required by a statistician throughout the lifespan of a trial; a good knowledge of the responsibilities of those departments with whom statisticians interact.
• A strong knowledge of the overall clinical trial process and of its application within Covance Clinical Development.
• Strong knowledge and 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 organise their own and others’ work.
• Strong delegation skills.
• Presentation skills.
• Excellent problem solving skills and a willingness to take ownership of decision-making. Evident application of past experience.
• Negotiation skills.
• Cooperative, team-oriented and proactive.
• Self motivation and self-reliance. Persistence and a strong determination.
• Ability to motivate others.
• An understanding of Covance Clinical development as a business, and its place in the global market.
• A proactive approach to the management of day-to-day activities and actions that may affect Covance as a business.
• The ability to apply practical project management solutions with a balance between client and Covance.
• The ability to plan and to adapt to changing situations.
• Able to identify obstacles that may limit the achievement of departmental strategies and objectives and to suggest appropriate contingencies.
• Flexibility.
• A professional approach at all times.
• Recognition of, and openness about, own limitations.
• Willingness and ability to challenge the views of others including those in more senior positions within Covance.
• The ability to identify and understand the reasons for actions within the organisation.
• Knowledge of financial metrics as applied to projects and departmental budgets.
• A proactive approach to building positive and productive working relationships with colleagues globally and with Covance’s clients.

Education:

• An MSc in a statistics subject, preferably with a strong medical statistics component.
• PhD preferred

At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.