Mgr, Biostatistics

Job Summary

With site/staff level of responsibility, manage a team of Biostatistics staff. Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying statistical methods to project work. Communicate on project progress, staffing concerns, including resource allocation, with the Director, Biostatistics, as needed. Perform expert reviews jointly with other Biostatistics management staff. Participate in client meetings. Participate as senior statistician on major projects, including developing/reviewing protocols, preparing analysis plans, overseeing the conduct of analyses, and preparing integrated clinical and statistical reports. Provide training, guidance and mentorship to lower level and new staff.

Responsibilities

• Leadership: Where relevant, may include: Serve as a statistical consultant for other members of the department and staff members from other Biostatistics departments within the company. Maintain knowledge and awareness of developments in Biostatistics and clinical trial methodology, and regulatory requirements that impact analyses. May participate as a member of a Data and Safety Monitoring Committee. May participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication, as approved. May participate as high level lead biostatistician on major project(s) including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or new drug application (NDA) sections, as required. Provide advanced technical expertise for internal and external clients. Assist and contribute to governance structures where relevant.
• Collaboration: Collaborate with business units with whom biostatistics closely interacts, such as data management (DM) and medical writing (MW), to facilitate existing processes and to identify issues requiring process change.
• Other Responsibilities: As defined on ad-hoc basis by senior managers. Perform Senior Biostatistical Review, where applicable.
• Hold at least bi-monthly meetings with direct reports to discuss, at a minimum: project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the teams utilization rates; the direct reports training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives.
• Develop and implement plans for measuring and improving employee engagement, ensuring global consistency.
• Collaborate with project leads to address work scheduling for current and projected projects, staffing needs, technological needs, and projected peak workloads, ensuring global consistency, where possible. Develop and manage associated action plans to hold members accountable.
• Efficiently conveying messages from leadership to direct reports and teams, as well as effectively communicating issues and opportunities up to leadership.
• Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover.
• Attend and participate in Bid Defenses, Kick off Meetings (KOM), as applicable. Support Request for Information (RFI), Request for Pricing (RFP), and budgets, as requested.
• Participate / Support internal and external audits and inspections, as required. Also ensure required staff is assigned, trained and prepared to support.

Qualifications

• Bachelors Degree Biostatistics or related field and 10 years relevant experience including 1 year in a leadership capacity Req Or
• Masters Degree Biostatistics or related field and10 years relevant experience including 1 year in a leadership capacity Req Or
• Ph.D. Biostatistics or related field and 3 years relevant experience including 1 year in a leadership capacity Req
• Typically requires 5-7 years of prior relevant experience, including 1 year experience managing staff or equivalent combination of education, training and experience.
• Requires knowledge of basic management approaches such as work scheduling, prioritizing, coaching and process execution.
• Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials.
• Strong working knowledge of SAS.
• Excellent knowledge of Clinical Data Interchange Standards Consortium (CDISC) guidelines.
• Proven Staff management skills, strong leadership, motivational and influencing skills.
• Strong organizational skills, metrics calculations, and time management skills.
• Strong verbal/written communication skills.
• Ability to work on multiple projects and manage competing priorities effectively.
• Effective mentoring and developed coaching skills.
• Ability to achieve results through proactive communication and facilitation in a matrix service delivery environment with shared accountabilities.
• Sound judgment, decision-making and problem-solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Ability to follow instructions/guidelines, utilize initiative and work independently.
• Understanding on basic Project Finance (EAC, forecasting, burn-rate monitoring and recognizing pursuing OOS where appropriate)
• Ability to drive business and financial results - short and long term.
• Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with direct reports, colleagues, and customers.
• Demonstrates good judgement in requesting input from senior staff. When requesting input, ensure clearly laying out the issue and required background details, articulating what support is needed; and what are the recommended actions.

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