ProPharma Group

Senior Biostatistician

ProPharma Group • $110K — $130K *
Western Springs, IL 60558In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Ph.D. or M.S. in Biostatistics required
  • 3+ years of relevant work experience
  • Experience in outsourcing industry essential
  • Knowledge of clinical trial design and statistical analysis
  • Familiarity with CDISC data structures, including SDTM and ADaM.
  • Proficiency in SAS and/or R programming support

Responsibilities

  • Lead statistical activities for clinical trials and oversee data analysis
  • Provide statistical expertise across clinical, data management, and regulatory teams
  • Ensure quality and accuracy of statistical deliverables like reports and graphs
  • Review clinical study protocols and CRFs for statistical appropriateness
  • Develop and maintain SAS programs per SOPs and regulatory guidelines
  • Stay updated on regulatory guidelines and industry standards
  • Mentor junior statisticians and enhance internal statistical processes

Benefits

  • Collaborative environment with cross-functional teams
  • Opportunities for professional growth through mentorship
  • Focus on innovation and adherence to regulatory standards
  • Engagement in diverse projects within clinical trials space
Full Job Description
Essential Functions:

  • Lead statistical activities for clinical trials and data analyses, including study design, statistical analysis plan development, and statistical analysis.


  • Provide statistical expertise to cross functional teams, including clinical operations, data management, and regulatory affairs.


  • Ensure the quality and accuracy of statistical deliverables, including statistical reports, tables, listings, and graphs.


  • Participate in the development and review of clinical study protocols and case report forms (CRFs) to ensure appropriate statistical analysis.


  • Develop and maintain SAS programs for statistical analysis in accordance with standard operating procedures (SOPs), good programming practices, and regulatory guidelines.


  • Keep up to date with regulatory guidelines and industry standards related to biostatistics and ensure compliance with these guidelines.


  • Participate in the development and maintenance of internal processes and standard operating procedures to improve statistical efficiency and consistency.


  • Provide guidance and mentorship to junior statisticians.


  • Other duties as assigned.


Necessary Skills and Abilities:

  • In-depth knowledge of statistical methodologies.


  • Excellent communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners.


  • Strong project management skills, with the ability to manage multiple projects simultaneously.


  • Knowledge of regulatory requirements and guidelines related to statistical analysis and reporting of clinical trial data.


  • Ability to program in SAS and or R.


Educational Requirements:

  • Ph.D. in Biostatistics, or M.S. in Biostatistics.


Experience Requirements:

  • 3+ years of relevant work experience.


  • Outsourcing industry experience required.


  • Experience in clinical trial design, sample size calculations, and statistical analysis.


  • Experience with CDISC data structures, such as SDTM and ADaM.

About ProPharma Group

ProPharma Group is a pharmaceutical consulting company that provides regulatory compliance, pharmacovigilance, and medical information services to clients in the healthcare industry. The company was founded in 2001 and is headquartered in Shawnee Mission, Kansas. ProPharma Group offers a range of services, including clinical trial support, quality assurance, and validation services. The company has worked with clients in a variety of industries, including pharmaceuticals, biotechnology, and medical devices.
Learn more about ProPharma Group
Size
500 employees
Industry
Pharmaceuticals & Biotech
Net Income
$5 million
Founded
2001
5 Year Trend
+30%
Revenue
$50 million
* Ladders Estimates

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