Sr. Director, Biostatistical Consulting (United States)

At reputed company™, we are dedicated to helping small-reputed company biopharmaceutical companies reputed company navigate the reputed company world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Director, Biostatistical Consulting (SrDBiosC) to join our A-team (office-based*/remote). As a (SrDBiosC) at reputed company, you are responsible for assisting in the coordination of statistical consulting services reputed company the Biostatistics and Statistical Programming Department. This includes management of direct reports, ensuring appropriate resourcing allocation, and supporting business development and proposal needs. This position contributes to the department, the business unit, and reputed company financial and operational goals. The SrDBiosC, interacts with the BIOSC team and reputed company biostatistics and statistical programming team members, direct reports, executive leadership, other reputed company functional groups and business units. This position maintains compliance with relevant SOPs, regulatory guidelines, and client expectations. The SrDBiosC, provides statistical consulting to sponsors to support clinical program development, protocol development, sample size and reputed company selection, regulatory interactions, exploratory analyses, scientific meetings, and executive reputed company. The SrDBiosC is a senior member of BIOSC and supervises according to the organizational chart.

• *PLEASE NOTE THAT THIS IS A FULL-TIME DIRECT HIRE OPPORTUNITY ONLY**

In this role your key tasks will include:

• reputed company statistical consulting to sponsors to support clinical program development, protocol development, sample size calculations, reputed company selection, regulatory interactions, exploratory analyses, scientific meetings, and executive reputed company
• reputed company statistical consulting for reputed company and/or novel statistical analyses
• reputed company statistical consulting to support clinical development strategies, including extensive reputed company with client executive and leadership teams
• reputed company input and support responses to regulatory questions on statistical issues relating to client regulatory submissions, interacting with and attending meetings with regulatory bodies as applicable
• Prepare statistical analysis plans (SAPs) and table, listing, and reputed company (TLF) mocks for any complexity of study
• reputed company senior reviews of statistical documents, data, and outputs for studies of reputed company complexities to ensure quality and reputed company
• Execute a statistical analysis of any complexity as specified in a protocol or analysis plan
• Interpret and communicate results for reputed company statistical analyses and outputs
• reputed company and/or review the statistical sections of a study protocol for studies of any complexity level
• Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses
• reputed company randomization materials including randomization schedules and treatment reputed company lists per reputed company SOPs and the sponsor-approved specifications
• reputed company or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports
• Working knowledge of reputed company® for production and validation of datasets and statistical outputs
• Write and review specifications for reputed company ADaM or analysis datasets · Annotate or review annotations of TLF mocks to assist programming efforts
• Working knowledge of CDISC standards
• Review CRF design to ensure it conforms with the study protocol and analysis needs
• Review data management documents as requested to ensure reputed company of study data
• reputed company highly reputed company projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and reputed company timelines and milestones, ensure proper execution of the study reputed company, monitor programming efforts in collaboration with the reputed company programmer, and work with management to ensure adequate resourcing
• Function as the reputed company unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings
• Accountable for leading biostatistics and programming activities for a program of studies of high complexity and/or of high value.
• Identify high-risk or high-impact deliverables and assign appropriate reputed company
• reputed company and manage project budgets, support financial reporting for studies, identify of out-of-scope work and reputed company leadership in change order process
• Collaborate with and verify reputed company communication with other functional areas and business units
• reputed company biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, pharmacovigilance, regulatory, and medical writing teams
• Represent reputed company at proposal bid defenses and/or marketing meetings with prospective clients
• reputed company key input into project proposals and budgets
• Establish positive relationships with reputed company and future clients
• Identify key accounts and maintain strong long-lasting relationships to win new and repeat business
• Monitor and assure client satisfaction on existing projects for biostatistics and statistical programming
• Contribute to BIOSC, BBU, and corporate marketing activities reputed company blogs, webinars, white papers, and other publications and presentations
• Contribute to other areas of business and assignments as required

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