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Manager Biostatistics

Allucent
Cary, NC
  • Posted: over a month ago
  • Full-Time
Job Description

CATO SMS and Pharm-Olam, LLC have merged to form Allucent!

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

Summary:

Provide leadership to staff executing the statistical programming and biostatistics on clinical trials, including acting as direct line management, senior oversight on sponsor activities, and maintaining budget and timeline expectations. Provide leadership in project management of trials across several therapeutic areas, ensuring that clinical trial activities are being completed by support staff. Provide input into company Standard Operating Procedures (SOPs) and processes.

Location: Wilmington, NC or Cary, NC location. Remote negotiable.

Responsibilities:

  • Apply performance indicators to assess ST/SP direct reports and communicate to ST/SP management
  • Ensure direct reports adherence to SOPs and other departmental standards/requirements
  • Encourage employee retention
  • Prepare and review proposals and budgets, utilizing company templates and coordinate with key input from ST/SP
  • Leading and/or supporting the planning, management, and execution of statistical and statistical programming activities for clinical trials, patient registries, regulatory submissions and other activities as requested by clients
  • Provide biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, pharmacovigilance, regulatory, and medical writing teams
  • Statistical consulting to support clinical development strategies, including extensive interface with client executive and leadership teams
  • Manage project budgets, support financial reporting for studies, identify of out of scope work and provide leadership in change order process
  • Interaction with FDA and other regulatory bodies as applicable
  • Identify, recommend and/or execute departmental initiatives, tools, and process solutions to enhance efficiency and quality
  • Support the corporate and operational infrastructure of the company, such as SOP and process development, business development, corporate strategy, resource utilization, hiring plans and growth, etc.
  • Mentoring biostatisticians and statistical programmers
  • Assist in the growth of the department through internal training, recognizing and correcting gaps in process or knowledge-base of the biostatistics group, and interviewing/selection of qualified personnel.


Requirements

Qualifications:

  • Education: Master’s degree or higher in Statistics or related field.
  • Experience: 6+ years relevant experience in clinical research. 1+ years relevant experience managing direct reports.
  • Equal Employment Opportunity and Affirmative Action

Benefits

  • Comprehensive benefits package
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for fully remote working or Hybrid Working Model
  • Leadership and mentoring opportunities
  • Internal growth opportunities and career progression
  • More task variety
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms

To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes.


#CS #LI-Remote #LI-TCW

Allucent

Address

Cary, NC
USA
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