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Associate Director of Biostatistics
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Associate Director of Biostatistics

Job Description

Allied Search Partners is looking for a candidate for a qualified Director of Biostatistics. Know someone for this position? We offer a $$ bonus if we place your referral in a position.


For a complete list of current Allied Search Partners openings Nationwide please go to:  http://www.alliedsearchpartners.com/careers.php



Position
:  Associate Director of Biostatistics

Schedule:  Full Time Permanent/Direct Hire

Location:  Boston, MA Area



To apply:
  Please send resume to [Click Here to Email Your Resum√©] or fax to      888 388 7572.  No other information about the location or name of facility is given at this time- you must submit a resume.

Things to remember:

  1. We are a staffing agency and conduct searches confidentially for our clients either at their request or to protect our resources involved in locating talent.  In order to facilitate this we must submit a resume to HR.
  2. Your resume will only be sent over for the position in this job description
  3. Our job is to connect talented individuals such as your self with top notch labs
  4. Full disclosure will be given once HR has requested an interview
  5. We do not send your information to current or past employers nor do we send your information to anywhere you request that it not be sent



Summary:
 

The Associate Director of Biostatistics will be a key member of several teams responsible for the development and submission of publications and presentations arising from our company-sponsored Phase 3 and 4 clinical and research studies. 


This position supports Global Medical Affairs and in-market products and the analyses will be mostly post-hoc and oriented toward the needs of health care provider and Payor audiences.  (Scientist audiences upon occasion.) 

You will provide input to cross-functional groups led by Medical Affairs who brainstorm, select, and prioritize new post-hoc analyses to meet specific strategic goals, and to groups who develop the abstracts and manuscripts.  The incumbent will furthermore be accountable for performing, QC’ing and fine-tuning the chosen analyses, plus explaining and interpreting findings for internal colleagues, management, and external authors – this is a hands-on role.  Statistical approaches and methods will sometimes need to be innovative or customized.  He/she would also “own” the tracking documents and file archives for analysis plans, programming code, output, and associated reports.  Will collaborate closely with internal statistics leaders, and when necessary, oversee the work of external biostatistics and programming contractors. This is an exciting opportunity to be part of an active, high profile, high-impact Medical Affairs Department, and to perform interesting and complex statistical analysis.


Duties/Responsibilities

  • Provide consultation, input and guidance to cross-functional groups charged with data mining and lifecycle management projects/studies.
  • Understand existing studies, datasets and analyses well enough to inform team members and guide strategy for future analyses.  Harmonize statistical strategies and methods across departments.
  • Provide consultation, input and guidance to cross-functional groups charged with development and submission of manuscripts, posters, slide presentations and abstracts.
  • Design, conduct, QC and report on agreed upon analyses.  This includes doing statistical programming and/or supervising external contractors doing such programming.  Analyses might be pre-planned or post-hoc, hypothesis testing or hypothesis generating, intended for dissemination or exploratory.  Present and/or explain findings to team members, internal managers, and/or external authors and experts.  Validate inferences.  Help craft listings and tables needed for abstracts, posters, slide decks, and manuscripts.
  • Establish and maintain collegial and collaborative relationships with cross-functional group members, Medical Affairs leaders, colleagues in affiliate countries around the world, external medical writers, and external experts and authors.
  • Work with Publication Leads and team members to respond in a timely manner to journal editor and reviewer comments.
  • Review draft abstracts and manuscripts according to deadlines, and when appropriate, serve as an Author.  In some cases, develop abstracts in close collaboration with external medical writers.  Serve as group’s expert on Methods sections.
  • Depending on resource needs, assign tasks and supervise the work of external contract statisticians and programmers.
  • Review draft presentations and training materials, including posters and slide decks, according to deadlines.
  • Assist in development of Statistical Analysis Plans (SAPs), sample size calculations, and feasibility determinations for Phase 4 and HEOR studies upon request.  Take lead role for stats sections of Phase 4 protocols as needed.  Consult regarding primary and secondary endpoints as per medical strategy.  Review SAPs from Investigator-sponsored Studies upon request.
  • Maintain expertise in current statistical methods and standards relevant to pharma and biotech industry applications.


Knowledge/Skills

  • Thorough and up-to-date knowledge of statistical methods, especially those related to human clinical studies, including time-to-event and recurrent event analysis, longitudinal data analysis (e.g. LME, GEE), missing data methods, nonparametric methods, responder and treatment failure analyses, data-mining techniques, meta-analysis
  • Thorough and up-to-date working knowledge of SAS and S-PLUS (or R).  Hands-on Programming experience.
  • Excellent interpersonal skills, negotiation skills, and verbal and written communications
  • Collaborative approach.  Ability to thrive in a fast-paced team environment, and also work independently on projects.
  • Ability to manage effectively one’s projects, and also to meet deadlines while maintaining high quality standards
  • Ability to explain strategies, approaches, methods, analyses, and findings to non-statistician group members and senior managers.  Ability to help others interpret results and place in context.

Job Requirements

PhD in Biostatistics or Statistics and 7 years of experience designing and conducting statistical analyses based on experimental data from in vitro, animal and/or human studies, including 5 years of experience designing and conducting statistical analyses from human Phase 3 and/or 4 clinical trial data, both pre-planned and post-hoc, in an industry setting (e.g., pharma, biotech, CRO)  

-OR-


Master’s degree in Biostatistics or Statistics and 10 years of experience designing and conducting statistical analyses based on experimental data from in vitro, animal and/or human studies, including 8 years of experience designing and conducting statistical analyses from human Phase 3 and/or 4 clinical trial data, both pre-planned and post-hoc, in an industry setting (e.g., pharma, biotech, CRO)


Preferred Qualifications

  • Specific knowledge and experience in analysis plans and techniques to support approved products in competitive markets
  • Experience analyzing data from Multiple Sclerosis studies
  • Clinical/Medical study design
  • Presentation skills
  • Experience publishing results
  • Experience working with external service providers
  • Budget management experience


*Need a similar position filled in your lab? Please contact us today to find out more on how we can help fill your open position. 

Job Snapshot

Employment Type Full-Time
Job Type Biotech, Health Care, Science
Education Graduate Degree
Experience At least 7 year(s)
Manages Others Yes
Relocation Yes
Industry Biotechnology, Healthcare - Health Services, Pharmaceutical
Required Travel None
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Associate Director of Biostatistics


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