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Clinical Sas Programmer

3-5 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Lead Statistician - Clinical Research

Job Description:
As a Lead Statistician, you will be responsible for managing statistical aspects of selected clinical research projects. You will ensure that projects are well-documented and in line with departmental and company SOPs, as well as manage the time of both yourself and your team effectively.

Key responsibilities include:

  • Serving as the lead statistician on selected projects.
  • Ensuring project documentation aligns with SOPs and working practices.
  • Interacting with sponsors on statistical aspects of the project.
  • Performing sample size calculations and providing input on study design during protocol development.
  • Reviewing protocols for completeness and appropriateness of clinical design and statistical analysis.
  • Writing protocol sections and developing randomization schemes.
  • Creating statistical analysis plans (SAP), including tables, listings, and graph specifications.
  • Specifying the structure of the analysis database, providing programming support for development and validation.
  • Producing and validating statistical analyses, appendices, and reports (including Integrated Summaries of Safety and Efficacy).
  • Contributing to the statistical methods section for Integrated Clinical Statistical Reports.

Qualifications:

  • BA/BS or equivalent degree in computer science, statistics, biostatistics, mathematics, or related field with at least 5 years of clinical research programming experience; OR MA/MS with 3 years of experience in clinical research programming.
  • Expertise in SAS or equivalent statistical/BI software; experience with SDTM, Tables & Listings, and ADaM is required.

Knowledge, Skills, and Abilities:

  • Proficient in one or more programming languages.
  • Ability to train and mentor others.
  • Strong attention to detail and problem-solving skills.
  • Ability to organize and manage multiple assignments with challenging timelines.
  • Excellent written and verbal communication skills.
  • Ability to adapt to changing priorities.

Interested candidates can send their profiles to contact@covalenttrainings.com or reach us at +91-9848733309 / +91-9676828080 for further guidance.