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Associate Director, Biostatistics

3 months ago

Cary, United States Allucent Full time
Job DescriptionJob Description

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 retention
  • Manage contract statisticians
  • Organize and conduct regular departmental meetings
  • Ensure quality, timeline, resources, utilization targets, and budget goals are met across the biostatistics department
  • Establish and monitor performance indicators to measure quality, margins, timelines, customer satisfaction, and other relevant project metrics
  • Recruit new staff and increase the size of the biostatistics/statistical programming team as required
  • Contribute to other areas of business as required

Requirements

To be successful you will possess:

  • Graduate degree (Master’s degree/local equivalent, or higher) in a relevant discipline including, but not limited to, statistics, mathematics, life science, epidemiology, or healthcare 
  • Minimum 12 years of relevant work experience 
  • Good knowledge of GxP 
  • Strong familiarity with relevant regulations and guidelines
  • GDPR/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements 
  • Working knowledge of computer systems, applications and operating systems 
  • Demonstration of critical thinking and analytic skills 
  • Strong written and verbal communication skills including good command of English language
  • Ability to work in a fast-paced challenging environment of a growing company
  • Strong individual initiative 
  • Excellent attention to detail and commitment to quality
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint
  • Ability to establish and maintain effective working relationships with co-workers, managers, clients, and vendors
  • Knowledge of SAS
  • Collaborative and client focused
  • Ability to effectively manage multiple tasks and projects
  • Strong leadership skills

Benefits

Benefits of working at Allucent include:

  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for remote/hybrid* working depending on location
  • Leadership and mentoring opportunities
  • Participation in our enriching Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-TCW #LI-Remote #LI-Hybrid