Principal Statistical Programmer

Clinical Waltham, Massachusetts


Description

Position Summary:

Apellis is looking for a Principal Statistical Programmer who is looking to fundamentally change the way Data and Analytics Solutions & Services are delivered!  The ideal candidate will be able to manage external vendors as well as spend a large part of their time programming. You will be responsible for leading and managing external vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components and ad hoc analyses. You will also produce tables, listings, graphs and datasets for internal ad-hoc analysis.  At Apellis, you’ll find an empowering environment where people are inspired to do great work, while learning and developing as professionals.  

Key Responsibilities Include:

  • Hands-on Programming for creation and QC of clinical Tables, Listings and Graphs
  • Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects via external staff oversight.
  • QC work performed by external vendors as well as other internal programmers.
  • Authors SDTM and ADaM dataset specifications including the identification of potential data issues or areas of critical data examination.
  • Works with Biostatistics on defining and documenting programming endpoint algorithms.
  • Manages the end-to-end programming of deliverables from CRF design through Electronic Submissions (ESUB) components ( e.g. reviewer’s guides, annotated CRF, define and SAS Transport Files)
  • Partners with Biostatistics to deliver high quality, submission ready statistical output.
  • Comfortable representing the Statistical Programming perspective to the study team and is often the sole functional representative.

Experience/Education:

  • 8+ years of related experience
  • BS/BA, MS preferred Relevant field such as Computer Science, Biology, Chemistry, Physics, Bioinformatics, and/or Mathematics
  • Prior experience in the Bio-tech industry is preferred

Skills, Knowledge & Abilities:

  • Knowledge of drug development process and clinical trials
  • Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines
  • Familiarity with Windows and SAS statistical software (and other statistical software such as JMP-Clinical, Pinnacle 21, and R)
  • Management skills, and ability to effectively lead and collaborate across functions
  • Comfortable working independently with supervision 
  • Strong attention to detail
  • Superior written and oral communication skills and the ability to work with different levels of management 
  • Highly motivated with the ability to be flexible in a fast-paced environment 

Physical Demands and Work Environment:

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.