Senior/ Principal Statistical Programmer | Long Term Contract | Remote

Posted 10 Days Ago
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6 Locations
In-Office or Remote
Senior level
Cloud • eCommerce • HR Tech • Information Technology • Analytics
The Role
Lead end-to-end statistical programming for ADaM datasets and TLFs; implement, validate, and maintain CDISC SDTM/ADaM standards; support regulatory submissions (ISS/ISE) and RTQs; develop reusable macros/functions and metadata specifications; work with RWD, biomarker data, external control arms, survival analysis, and propensity score methods.
Summary Generated by Built In

Title: Senior/ Principal Statistical Programmer(R)

Location: Remote

Duration: Long Term Contract

Salary: Open

Experience : 6-10+ Years

Notice : Immediate OR Within 15days


Requirements

We are looking for Senior / Principal Statistical Programmer(s) with strong hands-on expertise in R (mandatory) and SAS, solid CDISC (SDTM/ADaM) experience, and exposure to regulatory deliverables (TLFs, ISS/ISE, submissions)

Mandatory Skills & Experience:

  • 6–10+ years of experience in statistical programming in clinical domain (R/SAS)
  • Strong statistical programming expertise in R (at least 1-3+ Years)
  • Hands-on SAS programming experience required
  • Working knowledge of SQL and/or Python is an advantage
  • Experience with data reuse, historical trial data, Real-World Data (RWD), biomarker data, and External Control Arms

Core Responsibilities:

  • End-to-end statistical programming for ADaM datasets and Tables, Listings, and Figures (TLFs)
  • Programming support for ISS, ISE, regulatory submissions, and RTQs
  • Implementation, validation, and maintenance of CDISC SDTM and ADaM standards
  • Development and reuse of macros, functions, and programming utilities
  • Authoring and application of metadata specifications and derivations

Advanced (Good to have) Experience:

  • Experience in Oncology, Respiratory, or Immunology, along with RWD/RWE exposure, is a strong plus.
  • Experience with RWE oncology datasets (EHR, claims data)
  • Building and validating analysis cohorts

Hands-on experience with survival analysis and propensity score methods


Benefits

If Interested please send your updated resume to:[email protected]and include your rate/Salary requirement along with your contact details with a suitable time when we can reach you. If you know of anyone in your sphere of contacts, who would be a perfect match for this job then, we would appreciate if you can forward this posting to them with a copy to us.

We look forward to hearing from you at the earliest.

Skills Required

  • 6-10+ years statistical programming in clinical domain (R/SAS)
  • Strong statistical programming expertise in R (at least 1-3+ years)
  • Hands-on SAS programming experience
  • CDISC SDTM and ADaM experience
  • Exposure to regulatory deliverables (TLFs, ISS/ISE, submissions)
  • Working knowledge of SQL and/or Python
  • Experience with data reuse, historical trial data, RWD, biomarker data, External Control Arms
  • Experience in Oncology, Respiratory, or Immunology and RWE oncology datasets (EHR, claims)
  • Hands-on experience with survival analysis and propensity score methods
  • Availability immediate or within 15 days
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The Company
HQ: Cherry Hill, NJ
158 Employees
Year Founded: 2009

What We Do

Two95 International Inc., is a global technology firm specializing in enterprise solutions that evolves over BPM, Mobility, Cloud, Analytics, E-commerce & Social Business. Our client base includes several Fortune 500 and mid-market companies across industries and varying geographies. With vast knowledge and knowhow of 20 years in the IT field, we have been chosen as INC500 fastest growing company in North America in 2013. With the accolade of being ranked 11th in Human Resources by INC500, we have also been nominated as the 3rd fastest growing company in South Jersey by SJBM. We are ranked among the Top 20 IT Companies in New Jersey based on the year-on-year growth for the last 3 years. With a seasoned team of highly qualified personnel, our offices are located in New Jersey, Canada and India.

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