Manager, Statistical Programming

US-NJ-Princeton
Category
Biostatistics
Type
Regular Full-Time

Position Summary

The position will be responsible for providing support and technical guidance of statistical programming to clinical project teams, managing CROs programming output and, implementing quality control processes. Individual must have oncology experience.

Responsibilities

 

  • Effectively designs/develops SAS programs for clinical study reports, for regulatory submission, and for IB updates, DSUR, PSUR etc.
  • Supervises CROs and contracted programmers to ensure quality performance and meeting of timelines of assigned SAS programming deliverables.
  • Monitors CRO budgets, RFP, invoices management, scope of work etc. in regards to SAS programming work.
  • Keeps management current on project status and provides ongoing risk assessments.
  • Develops complex SAS programs and performs quality control checks for SAS code and outputs produced by CROs as required.
  • Identifies problems and develops global tools that increase the efficiency and capacity.
  • Responsible for maintaining/archiving medical database, SAS programs and results, and documentations.
  • Organizes and/or participates in technical meetings including internal and external representatives.
  • Assists Taiho Japan in harmonizing the data management and statistical analysis aspects throughout all Taiho companies.

Qualifications

 

 

Educational Requirements:

  • Bachelor/Master's Degree/in Biostatistics, Mathematics, Statistics, Computer Science, Life Science (or equivalent degree)

 

Experience:

  • A minimum of 5 years of relevant pharmaceutical industry work experience.
  • Experience writing SAS programs to create data sets, tables, figures, and listings reporting results of clinical trials.
  • Experience with creating all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE.
  • Experience with SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
  • Experience with the CDISC SDTM and AdaM models and transforming raw data into these standards.
  • Experience working with all types of safety data and coding dictionaries commonly used by the pharmaceutical industry.

 

Other Skills and Abilities:

  • Excellent writing skills.
  • Highly detail and quality oriented.
  • A positive attitude, flexibility and a proactive thought process.

Language Skills:

  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
  • Ability to write speeches and articles for publication that conform to prescribed style and format.
  • Ability to effectively present information to top management.

Reasoning Ability:

  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical form and deal with several abstract and concrete variables.

 Computer Skills:

  • Strong computer skills in industry standard statistical programming.

Physical Demands:

  • While performing the duties of this job, the employee is frequently required to sit, talk and hear.
  • The employee is occasionally required to walk.
  • The employee must utilize close vision and be able to adjust focus.
  • Infrequent travel is anticipated.

Work Environment:

  • The noise level in the work environment is usually quiet.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The incumbent in this position may be required to perform other duties, as assigned.

 

 

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