Senior Biostatistician

Location:Deerfield, ILPosted Date:Apr 29, 2011Position Type:Full TimeJob Code:556Required Education:Bachelors DegreeAreas of Expertise Desired:Biometrics

Description

The Senior Biostatistician provides technical guidance and implementation of statistics issues at both a strategic and detailed level. This individual works closely with and informally leads members of Biometrics to provide reliable and timely input and deliverables for drug development teams. This position will report to the Principal Biostatistician, US Biometrics.

 

 

ESSENTIAL FUNCTIONS:

Collaborates with biometric programmers, data managers, and medical writers to ensure high quality and statistically accurate output in the support of clinical programs. Creates randomization requirements, reviews CRFs, and ensures accuracy of dataset specifications. Independently programs or verifies programs as necessary. Executes standard reports within internal Biometrics systems.

 

Consults with medical, regulatory, and other staff to understand scientific questions of interest, proposes and negotiates statistically sound solutions to those questions, and delivers answers to those questions with appropriate statistical interpretation. Exhibits a significant understanding of the medical considerations of the therapeutic area.

 

Co-authors written documents such as protocols, clinical study reports, regulatory correspondence, manuscripts, and presentation slides. Drives statistically written documents such as statistical analysis plans and mock tables/listings/figures. Reflects appropriate implementation of statistical methodology and thinking in all of these documents.

 

Evaluates and investigates applied and theoretical statistics considerations in proposing optimal solutions to scientific problems. Applies these methods seamlessly in project work. 

 

Independently participates in project teams and relevant core development teams by actively serving as the natural leader for Biometrics. Supports Biometrics positions by demonstrating command of phase I-IV drug development process. Provides strategic thinking into the development of compounds via master development plans, appropriately challenges scientific and operational issues, and engages other members of Biometrics as needed.

 

Effectively communicates with regulators in written and oral form with support of a seasoned statistician with deep regulatory experience.

 

Implements effective project management in the coordination of Biometrics deliverables so as to preserve resources and meet team timelines. Works through vendors to achieve the same.  Leverages standardization to achieve efficiency.

 

Understands and conducts work consistent with GCPs, ICH guidances, internal SOPs and training, and international regulatory requirements. Documents work in accordance with these documents. Proposes improvements to internal standards and processes.

 

Maintains and shares state of the art knowledge in statistics through an awareness of advances in the field, continuing education courses, conference participation, and internal/external networking. Contributes to internal forums on teaching and training activities. Maintains cutting edge knowledge in a specific area of statistical methods.

 

REQUIRED SKILLS AND EXPERIENCE:

Master's degree in statistics, biostatistics, or closely related field.

 

5+ years of experience in a pharmaceutical, biotech, medical device, CRO or related environment.

 

2+ years of SAS programming experience, including inferential statistics procedures.

 

2+ years of experience of project management.

 

Proven ability to manage multiple projects simultaneously, taking initiative and working independently.

 

Demonstrated creative thinking and problem-solving skills in the realm of statistics.

 

Strong leadership, negotiation, teamwork and communication skills.

 

PREFERRED EDUCATION, SKILLS AND EXPERIENCE:

Ph.D. in statistics, biostatistics, or closely related field with 2+ years of experience in a pharmaceutical, biotech, medical device, CRO or related environment.

 

Exposure to neuroscience projects.

 

Experience with registries, REMS programs, or post-marketing surveillance.

 

Exposure to regulatory submissions.

 

Working knowledge of S-Plus or R.

 

Experience managing vendors.

 

Understanding and application of advanced statistical methodology such as Bayesian methods, data imputation strategies, data mining techniques, meta-analysis, adaptive designs, and simulation.

 

Exposure to advanced, niche statistical software such as BUGS and Cytel suite.

 

CB* BSP~

Requirements

See Above