Associate Director, Biostatistics (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 Associate Director, Biostatistics (aDBios) to join our A-team (hybrid*/remote). As a aDBios at Allucent, you are responsible for assisting in coordination of activities of the Statistical department of Allucent. This position coordinates and monitors statistical operations activities including management of direct reports, ensuring appropriate resourcing allocation, supporting business development and proposal needs, providing statistical project oversight, mentoring and training junior staff, and monitoring project budgets.  This position may lead projects, write statistical documents and statistical sections of study documents for studies of all complexity, and/or provide senior review of statistical documents and outputs.  This position may assist in the programming of datasets and outputs using SAS®. The aDBios will regularly interact with other members of the Allucent biostatistics project team, direct reports, upper management, and clients. 

The aDBios is a member of the Biometrics staff.

In this role your key tasks will include:

Biostatistics:

• Knowledge in clinical research with emphasis in the development and support of the analysis of clinical trial data  

• Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for a study of any complexity  

• Familiarity with complex statistical methods and concepts  

• Provide senior reviews of statistical documents, data, and outputs for studies of all complexity 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 

• Provide input and support responses to regulatory questions on statistical issues relating to client regulatory submissions, attending regulatory meetings if requested 

• 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 

• Lead management of project budgets, the identification of out-of-scope work, and the change order process 

• 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

Management, Leading & Development:

• Actively support staff learning & development within the company  

• Identify, recommend, execute, and coordinate departmental initiatives, tools, and process solutions to enhance efficiency and quality 

• Provide mentoring to junior staff 

• Manage direct reports 

• Apply performance indicators to assess direct reports 

• Ensure direct reports' adherence to SOPs and other departmental standards/requirements 

• Ensure quality, timeline, resources, and budget goals are met in direct reports 

• Encourage employee