Sr. Director or Director, Biostatistics

Job Number:    #0229


Location:      Montgomery County area of Maryland
Company:    Well established biopharmaceutical company

Focus:           Regenerative therapies - cell therapy
Misc:             There are six key management employees listed at this company and we are responsible for the recruitment of three of them



POSITION SUMMARY                             

This person will be the lead statistician for multiple projects with varying levels of complexity and will act as the primary contact for all biostatistics related activities and projects.   In addition, this person will help manage clinical trials by providing accurate and consistent information to the Company and other cross-functional departments.

REPORTS TO:         Chief Medical Officer

LOCATION:            Montgomery County Maryland


Essential Duties & Responsibilities

  • 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 the 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 an 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. 

Education & Experience

  • Master’s Degree or Ph.D. in Statistics or Biostatistics; with approximately 10 or more years pharmaceutical experience

  • Proven knowledge and expertise in statistical 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




Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.


NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.


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