Principal Statistical Programmer

  • 500 River Ridge Dr, Norwood, MA 02062, USA
  • Full-time

Company Description

Corbus Culture:

Corbus is a close-knit team of over 150 employees who are high-achievers, innovative, creative and, above all else, passionate about what we do. We hire for personality as well as for skill.

You must thrive in an entrepreneurial and autonomous environment where you will succeed based on your contribution and work ethic, not on your title or rank. At Corbus we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here. Positive, team-oriented people work at Corbus and are rewarded with fun perks like weekly food deliveries to our kitchen, a monthly in-house massage therapist, company-paid classes with Title Boxing, and organized company activities and outings.  Additionally, Corbus offers an attractive, comprehensive benefits package.

About Corbus:

Corbus Pharmaceuticals Holdings, Inc. (NASDQ: CRBP) is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its industry leading pipeline of endocannabinoid system-targeting drug candidates. The Company's lead product candidate, Lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.

Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2nd generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist specifically designed to eliminate blood-brain barrier penetration and brain CB1 receptor occupancy that mediate the neuropsychiatric issues associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. CRB-4001 is scheduled to enter a Phase 1 study in 2019 followed a National Institutes of Health (NIH)-funded first-in-patient Phase 2 study.

www.corbuspharma.com

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer

Job Description

The Principal Statistical Programmer is responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced clinical trial programming. May also perform analyses and programming to generate post-hoc requests, or for manuscripts and presentations. 

This is an onsite position and reports to Director, Statistical Programming, working closely with Biostatistics, Data Management, Physicians, Clinical Operations, Regulatory, Research, Business Development, and other related disciplines, as well as CROs and other outside vendors.


Primary Responsibilities:

  • Serves as statistical programmer to support Corbus’ clinical programs, and works collaboratively within Clinical Development (and in conjunction with CRO’s) to meet deliverables and timelines for statistical programming and reporting  
  • Develops SAS programs to perform statistical analyses (i.e., generating tables, listings, figures and inferential statistical output) supporting regulatory requests, publication/commercial requests, and ad-hoc analyses
  • Reviews and validates CRO deliverables
  • Works closely with Data Management and Biostatistics, to ensure final databases, analyses, and reports are accurate
  • Responsible for insuring quality and integrity of statistical programming to meet current regulatory requirements and industry standards
  • Perform quality review of SAS code and output produced by other Statistical Programmers and Statisticians
  • Develop/Review TFL shells and SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues
  • Collaborate with Data Managers to provide input on CRF design, CRF annotation, edit checks, and data review plans
  • Ensure the proper collection, management, and storage of clinical trial data (according to regulatory requirements)
  • ​Responsible for oversight, QC and coordination of CDISC/SDTM mapping and compliance with applicable standards

Qualifications

SKILLS & REQUIREMENTS:

  • Bachelor’s Degree in statistics, mathematics, computer science, or related scientific/medical field. Master’s Degree preferred
  • 5+ years of (SAS) statistical programming experience in a clinical trial setting (industry/CRO)
  • Advanced SAS programming skills - procedures and options commonly used in clinical trial reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures desirable
  • Hands-on knowledge of CDISC/SDTM/ADaM standards and Implementation Guidelines. Experience annotating CRFs to CDISC standards preferred
  • Experience using and configuring Pinnacle 21 is desirable
  • Ability to review Define-XML for usability and compliance with CDISC standards. Familiarity with XML and XML validation tools preferred
  • Understanding of FDA Data Submission requirements
  • Knowledge of drug development process and regulatory requirements, including ICH/GCP guidelines and 21CFR Part 11 standards
  • Knowledge of clinical database design, specifically electronic data capture using systems such as Inform, RAVE, and Oracle
  • Excellent verbal and written communication skills
  • Proficiency with Microsoft Office (Excel, Word, Outlook)
  • Fluent in spoken and written English
  • Experience working with safety data and coding dictionaries (MedDRA & WHODRL)

 

 

 

 

 

 

Additional Information

All your information will be kept confidential according to EEO guidelines.