Sr. Director, Biostatistical Consulting (United States)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex 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 Allucent, you are responsible for assisting in the coordination of statistical consulting services within 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 Allucent financial and operational goals. The SrDBiosC, interacts with the BIOSC team and Allucent biostatistics and statistical programming team members, direct reports, executive leadership, other Allucent 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 endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions. 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:
• Provide statistical consulting to sponsors to support clinical program development, protocol development, sample size calculations, endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions
• Provide statistical consulting for complex and/or novel statistical analyses
• Provide statistical consulting to support clinical development strategies, including extensive interface with client executive and leadership teams
• Provide 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 figure (TLF) mocks for any complexity of study
• Provide senior reviews of statistical documents, data, and outputs for studies of all complexities to ensure quality and integrity
• Execute a statistical analysis of any complexity as specified in a protocol or analysis plan
• Interpret and communicate results for complex statistical analyses and outputs
• Develop 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
• Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications
• Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports
• Working knowledge of SAS® for production and validation of datasets and statistical outputs
• Write and review specifications for complex 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 integrity of study data
• Lead highly complex projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and achieve timelines and milestones, ensure proper execution of the study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate resourcing
• Function as the lead 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 oversight
• Lead and manage project budgets, support financial reporting for studies, identify of out-of-scope work and provide leadership in change order process
• Collaborate with and verify open communication with other functional areas and business units
• Provide biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, pharmacovigilance, regulatory, and medical writing teams
• Represent Allucent at proposal bid defenses and/or marketing meetings with prospective clients
• Provide key input into project proposals and budgets
• Establish positive relationships with current and future

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