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Principal Statistical Programmer, Late Stage - US based, Remote

Company: POINT Biopharma
Location: Garland
Posted on: May 14, 2022

Job Description:

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location of work

The position will be working remotely with the anticipation of travel for team and client meetings. Currently, our employees are working remotely and located within the Eastern Time Zone. To work in synergy, it is preferred that our applicants are working within the same Eastern Time Zone to accommodate team and client meetings.

Overview

The Principal Statistical Programmer will be responsible for providing timely support to the study team on all programming requests, including internal programming deliverables requested by POINT study team and oversight of CRO statistical programming activities.

This position will report to Director of Statistical Programming and will work closely with cross-functional teams on single possibly multiple clinical development programs. Typical requests include internal ad-hoc requests, periodic safety and efficacy updating report, TLF output supporting presentations, publications and health authority submissions.

Responsibilities

  • Demonstrate extensive understanding of SAS programming concepts and techniques in pharmaceutical/biotechnology setting, independently develop, test, and document SAS programs and macros for programming deliverables.
  • Create, maintain the programming specifications for the data sets, review the programming specifications provided by CRO.
  • Create and validate SAS outputs including SDTM and ADaM datasets, and TLFs or ad-hoc output per study team request.
  • Responsible for the creation and accuracy of regulatory submission data and clinical summary report package. Understand and perform in accordance with regulatory standards.
  • Create and validate SAS outputs supporting presentations, publications and health submissions.

    Requirements
    • BS in computer science, mathematics, statistics or related analytic field, MS in statistics/biostatistics highly preferred.
    • Minimum 7 years of hands-on statistical programming experience in CRO, biotech, or pharmaceutical setting, including SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro languages.
    • Working knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of related disciplines, biostatistics, statistical programming and CDM.
    • Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define package, reviewer's guide and submission standards.
    • Working knowledge GCP/ICH standards, 21 CFR Part 11 and FDA requirements with prior experience filing NDA/MAA/BLA preferred.
    • Must have oncology working experience with solid tumor study experience highly preferred.

      Competencies
      • Strong analytical and problem-solving skills
      • Ability to work independently, while being a collaborative team member in a dynamic fast-paced and lean environment
      • Organized with high attention to detail, accuracy and completeness
      • Excellent interpersonal, and verbal and written communication skills

        Why joining POINT today will be the right career move for you:

        There is no shortage of demand for smart, qualified and hardworking people like yourself - and we strongly believe POINT is the right career move for you. Here is why:
        • You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
        • You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
        • You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
        • Most importantly, you will spend everyday working on something important

          If what we are saying resonates with you, please submit a cover letter and resume.

          Benefits
          • Health Care Plan (Medical, Dental & Vision) - effective day 1
          • Retirement Plan (401k)
          • Income Protection Insurance - (Life AD&D, Short & Long-term disability) - 100% employer paid
          • Voluntary Income Protection - Premiums paid by employee
          • Paid Time Off (Vacation, Sick & Public Holidays)
          • $500 fitness reimbursement per year
          • $50 cell phone reimbursement per month

            All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

            POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

            We do not accept unsolicited inquiries or resumes from agencies.

Keywords: POINT Biopharma, Garland , Principal Statistical Programmer, Late Stage - US based, Remote, IT / Software / Systems , Garland, Texas

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