Biostatistician

Job Summary:

STATKING Clinical Services (SCS), a contract research organization for the pharmaceutical and medical device industries located in Hamilton, OH, is seeking a Biostatistician to provide statistical support for clinical trials. The qualified individual will consult on clinical trial design, write statistical sections of clinical trial protocols, Statistical Analysis Plans, and other statistical documents, and review data analysis output. He/she will lead a team of 2-4 statisticians.

The skilled applicant would have 3-5 years’ experience in a Clinical Research Organization; thorough understanding of the theory behind statistics as well as the ability to explain it to non-statisticians. SAS programming basic skills are necessary to perform the day-to-day duties and liaising with the programming team at SCS. Experience presenting in front of agencies like FDA and EMA is a desirable trait as well.

SCS has provided clinical trial services to our clients for over thirty years. At SCS you will be an integral part of our statistical team. You will work on several projects in a variety of drug, biologic, and medical device areas, providing support for new product development and regulatory submissions.

Essential Functions:

• Writing Statistical Analysis Plans
• Consulting with clients on study design, including sample size calculations
• Writing internal SAS programming instructions
• Reviewing statistical documents
• Writing statistical sections for a clinical study protocol
• Reviewing tables, listings, and figures
• Writing statistical analysis reports and the statistical sections for a clinical study report
• Interacting with regulatory authorities
• Leading periodic team meetings (meeting agendas and minutes) either internal or with the sponsors.
• Review/Update internal documents related to the conduct of clinical trials.

Job Qualifications: General Knowledge, Skills, and Abilities (KSA’s) required

• A MS, or PhD in Statistics or Biostatistics; Analytical Science, or Data Science
• Understanding of clinical trials
• Excellent oral and written communication skills
• Ability to work both independently and in a team environment
• Proficiency with Microsoft Word
• 2-3 years SAS® programming experience
• Ability to multi-task and think on your feet