Statistical Programmer Consultant (Chicopee)

Compensation

: $99,550.00 - $150,310.00 /year *

Employment Type

: Full-Time

Industry

: Scientific Research



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Job Description

Responsibilities

  • Lead/Review SDTM specs, acrf, datasets, Defines, Reviewers Guide for regulatory, CDISC compliance and SAP
  • Utilize SAS to generate and validate CDISC SDTM, ADaM compliant datasets and TLFs based on SAP
  • Utilize SAS to generate any ADHOC related analysis for various needs (internal, publications, ect.)
  • Oversight of CROs to ensure quality and timely deliverable
  • Collaborate with cross functional teams on ongoing basis representing statistical programming on Study Management Teams
  • Review eCRFs, DMP and other Data Management documents
  • Review Statistical Analysis plan and other related docs
  • Work independently
  • Manage multiple projects/tasks, and appropriately prioritize these tasks
  • Qualifications

    The successful candidate for this position will have a proven track record of SDTM/ADAM, TLFs programming supporting clinical trial execution and regulatory submissions, and must therefore:

  • Have strong technical SAS programming skills (at least 7-8 years) that can be used in producing various types of outputs: datasets, TLFs.
  • Have strong technical skills to produce deliverables either on scheduled or ADHOC basis.
  • Have at least 5-7 years of experience in the pharmaceutical industry;
  • Bachelors degree in statistics, mathematics, computer science, management information systems, or related field of study is required; MS in statistics or biostatistics is desirable;
  • Strong knowledge with FDA and CDISC/SDTM requirements for compliant datasets, programs, and validation processes is a must have;
  • Experience with Spotfire and R, a plus
  • Thorough understanding of the clinical drug development process (clinical trials Phase I-IV);
  • Heavily involved in designing, developing & validating CDISC SDTM specifications and datasets for clinical trials;
  • Experience with producing outputs submitted to the FDA and other regulatoryagencies (IND, ISS, ISE, Annual Reports, DSUR, post marketing support, etc.);
  • Excellent knowledge of clinical trial research methodologies, CDISC, ICH, GCP and 21 CFR Part 11 rules and regulations;
  • Demonstrable abilities to work on most tasks independently (with limited guidance and supervision);
  • Excellent organizational skills: can prioritize multiple tasks and goals to ensure the timely completion
  • Excellent communication skills with the ability to quickly adapt to a fast-paced environment;
  • Expectedto communicate regularly with CRO vendors to ensure quality and on-time delivery and withmembers of various internal teams (data science, medical science, and program development) to provide delivery-related updates;
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

  • Associated topics: biostatistics, data analyst, probability, statistics, c * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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