Assoc Dir, Biostatistics Rwe

Essential Functions
Leadership: Serve as a Biostatistical 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 on analyses.
Represent clients at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee.
As approved, participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication.
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 or eSubmissions and/or new drug applications (NDA), as required.
Provide advanced technical expertise for internal and external clients.
Assist and contribute to governance structures where relevant Risk Management: Identifies risks to project delivery and/or quality.
Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions.
Handles study level escalations and assist in high level escalations that might impact the account relationship.
Escalates for support to business segment owners/client owners/managers.
When managing leads, operate as an escalation point for biostatistical team leads 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 team's utilization rates;
the direct report's training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates;
personnel issues;
and career or training objectives.
Create and implement plans for measuring and improving employee engagement ensuring global consistency.
Maintain open and regular communication with direct reports to ensure a supportive working environment.
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.
Prepare, present and respond in bid defense meetings and discussions.
May input into more complex requests for information (RFIs) or requests for proposal (RFPs).
Liaise with Business Development to give timely inputs regarding the feasibility of all new proposals going out to clients.
Contribute at IQVIA internal cross-functional project team meetings interfacing with other functional leads customer project status meetings and oversight group meetings.
Subject Matter Expert (SME) Meetings, as appropriate.
Qualifications
Bachelor's Degree Biostatistics or related field and 7 - 10 years relevant experience including 2 years experience managing staff Req Or Master's Degree Biostatistics or related field and 7-10 years relevant experience including 2 years experience managing staff Req Or Ph.D.
Biostatistics or related field and 5 years relevant experience including 2 years experience managing staff Req Typically requires 7-10 years of prior relevant experience, including 2 years experience managing staff or Equivalent combination of education, training and experience.
Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one department or multiple related departments.
Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials.
Strong working knowledge of SAS.
Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium (CDISC)/ADaM).
Strong business acumen;
financial management and budgeting skills.
Proven Staff management skills, strong leadership, motivational and influencing skills.
Strong project management;
strategic planning;
delegation and organisational skills.
Proven ability to work on multiple projects and manage competing priorities.
Confident in raising and discussing sensitive topics without management intervention and in communicating effectively with senior levels of management in both IQVIA and customer organizations.
Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues.
Excellent communication (both verbal and written), presentation and negotiation skills Ability to establish and maintain effective working relation