Skills:

Company: Nimbus Search Partners

Location: Gaithersburg, MD

CloseDate: 10/30/2017

Address: Gaithersburg, MD 20850

Industry: Life Science

EmploymentType: Full-Time

Salary: Competitive

Description:

TITLE:             Associate Director, Biostatistics
 
Location:       Gaithersburg, MD
                                   
 
Background: Our client is a Global clinical-stage biopharmaceutical company, which is in the process of expanding its US team in Gaithersburg, Maryland.
 
Reporting to the Chief Medical Officer, this is an exciting opportunity to lead the Company’s Biostatistics function.
 
Summary:    

This Position will serve as a hands-on lead statistician for multiple projects with any level of complexity.  Acts as the primary contact for all biostatistics related activities on assigned projects.   Helps manage clinical trials efficiently by providing accurate and consistent information to Company business and other cross-functional departments.

Essential Functions: 

  • Collaborates in the process of protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol.  Sample size calculations may require some literature search to ensure that the study assumptions are correct.
  • Writes and reviews Statistical Analysis Plans (SAPs) based on the protocol, including development of well-presented mock-up displays for tables, listings, and figures.  Collaborates with Clinical Development and other teams.
  • Directs the activities of other Biostatistics personnel on assigned projects to ensure timely completion of high quality work.  Provides independent review of project work produced by other statisticians in the department.
  • Participates in project teams as Biostatistics representative, interfacing as necessary with other departmental project team representatives.
  • Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
  • Participates in Data Safety Monitoring Board and/or Data Monitoring Committee activities
  • Conducts and participates in review and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP.
  • Discusses time estimates for completion of study related activities with stakeholders and proactively communicate any issues/challenges that would impact meeting these timelines.  Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. 
  • Ensures proper study closeout by documenting and archiving study related materials according to Standard Operating Procedures (SOPs), and/or sponsor instructions.
  • Generates and/or reviews randomization schedule(s) to ensure there are no errors present and sponsor and protocol requirements are met.  Performs ongoing monitoring of actual randomization scheme applied by IVRS/IWRS.
  • Active member of protocol development core team providing input in design, outcome measures, endpoint assessment, and sample size/power calculations
  • Plan and manage Biometrics related submission activities
  • Will have familiarity with CDISC and Biometrics related Guidelines
  • Represent the company at FDA/EMA meetings, including Advisory Committee meetings
  • Displays willingness to work with others and assist with projects and business unit initiatives as necessary to meet the needs of the business. 

Requirements:
Qualifications
  • Master’s Degree in Statistics or Biostatistics; PhD preferred with 10+ years of pharmaceutical experience
  • Proven knowledge and expertise in statistics methodology and its application to clinical trials in pharmaceuticals/biotechnology environment
  • Solid knowledge and experience in drug development process
  • SAS programming experience
  • Knowledge of statistical sample size calculations software
  • Experience interpreting meta-analyses and non-inferiority methodologies
  • Experience with modeling and bootstrapping methods
  • Strategic thinker
  • Experience interacting with the FDA and global regulatory authorities
  • Prior experience with regulatory submissions
  • Previous regulatory agency experience preferred
  • Able to thrive in a small group setting, possesses high energy hands-on attitude
  • Strong leadership, cross-functional collaboration, communication and presentation skills
  Other Responsibilities:  Performs other work-related duties as assigned.   Travel may be required (up to 25%).