Statistical Analyst/Senior Statistical Analyst

Location
Gaithersburg, MD
Posted
Jan 07, 2021
Required Education
Bachelors Degree
Position Type
Full time

Statistical Analyst/Senior Statistical Analyst

Altimmune (NASDAQ: ALT) is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating treatment for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.

Job Description:  Collaborates with clinical team to oversee data management activities and programming in support of clinical trials and regulatory submissions. Assists to determine study design, develop statistical sections of study protocol, write statistical analysis plan and study reports. Responsible for completeness and accurate delivery of TFLs and study data. Critical member of cross-functional product development teams.

Essential Functions:

  • Assists clinical team in designing clinical trials and preparing statistical sections of clinical study protocols and statistical analysis plan
  • Reviews and tests electronic data capture system, Case Report Forms, TFLs shell and specification to ensure consistency with study protocol and clinical requirements
  • Reviews study data management documents (Data Management Plan, EDC System User’s Guide, etc.) prepared by CROs
  • Ensures timely and accurate delivery of TFLs and completeness of study data captured in an electronic database
  • Collaborates with vendors, specialty labs, and CROs in timely and accurate transfer of study data
  • Produces tables and listings in R or SAS for clinical study reports, interim reports, and ad-hoc reports
  • Supports clinical and non-clinical team in performing ad-hoc statistical analysis with visualizing data in R and SAS
  • Interprets clinical trial data and contributes to preparation of clinical manuscripts and regulatory submission documents
  • Responsible for storing and organizing clinical study data on company servers

Job Requirements (essential knowledge, skills and attributes):

  • BS or MS in Statistics, Biostatistics, Data Analysis, or related field
  • MS with 2 years of experience or BS with 4 years of experience in biotech, pharma or CRO
  • Proficient with R and SAS (Base SAS, SAS/STAT, SAS Macro and SAS SQL) programming
  • SAS Certified Base Programmer and Advanced Programmer are preferred, but not required
  • Knowledge of MS Excel, Word, Access, and PowerPoint is essential
  • Experience with study design and application of statistical methods for clinical trials
  • Experience with CDISC standard datasets (SDTM and ADaM) is desirable 
  • Excellent organizational and communication skills and strong attention to details
  • Ability to manage multiple tasks and work independently.