Director of Stats JD - PGxHealth a Division of Clinical Data

Position Description

Location: New Haven, CT
JOB SUMMARY: This position works with other statisticians and biomedical scientists to provide statistical support for a wide variety of internal and client-driven projects.


DUTIES AND RESPONSIBILITIES:

• Participates in the design and analysis of clinical studies related to internal and external client products. These products may include the incorporation of genetic/pharmacogenetic analysis.
• Participates in due diligence of potential compounds for in-licensing
• Ensures that appropriate analysis procedures are used (in accordance with ICH, FDA Guidelines and other appropriate regulatory guidelines), and that final reports effectively describe statistical methods and results of analyses
• Performs statistical and bioinformatic analyses using standard, proprietary, and third-party tools and techniques
• Writes statistical sections of reports, publications, patents, and regulatory submissions
• Collaborates in the development of new statistical/analytical methods, including generating concepts, implementing them, and devising and performing tests
• Evaluates and integrates third-party software and data
• Reviews new literature for applicability to company needs
• Collaborates with other groups within the company, such as Biomarker Development, Therapeutic Development, and Medical Affairs
• Represents the company at appropriate meetings
• Provides oversight of data management activities including establishment of databases, privacy and security issues, data cleaning, and other relevant duties
• Programmatically accesses public databases such as HapMap to guide the generation and interpretation of internal data
• Works closely with bioinformatics and other departments to ensure a smooth integration of clinical data, statistics, bioinformatics, and genomics


KEY RELATIONSHIPS:

• Internal 80%

• External 20 %

MANAGERIAL RESPONSIBILITY (Number of reports):

• Direct 1

• Indirect 1

BACKGROUND REQUIREMENTS:

Education, Experience, and Knowledge

• PhD in Statistics or Biostatistics with 2 to 3 years of clinical trial design methodology, regulatory requirements, and analysis experience.
• 3+ years of relevant experience programming with SAS and other analytical products
• Ability to work on multiple tasks and meet project deadlines

Skills and Abilities
Fluency in SAS, R/S-Plus, and Perl or another scripting language is required, as are strong written and oral communication skills. Demonstrated ability to interact confidently with members of clinical, scientific, regulatory and business teams.

Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors.

MATHMATICAL SKILLS
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

PHYSICAL DEMANDS
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

How to Apply

Application Instructions / Send a Resume