Sr Programmer Analyst- CDISC SDTM (remote)

Company: Thermo Fisher Scientific
Location: Morrisville
Posted on: March 17, 2023

Job Description:

Are you ready for an amazing opportunity that truly will make a difference, with an amazing team and incredible leadership?If so, you are in the right place!

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

The Data Transformation and Submission(DTS) group within our Biostatistics & Programming department performs active global CDISC submission development for clients in our Biotech, Biopharma and FSP groups. There is also responsibility for Spotfire exploration, SDTM, DSUR reporting, eCRT (Define.xml) as well as cross functional development initiatives with various internal departments, including CDM, Early Dev Services, PVG, etc.The DTS group also works on many stand-alone studies that are led and driven fully within the group.

As Senior Programmer Analyst within DTS, you will perform specification, development, quality validation and regulatory submission compliance for PPD developed CDISC SDTM and CDISC eCRT (Define.xml) programming deliverables, using Windows SAS Grid. You will deploy Spotfire dashboards, Safety notifications and reporting for Medical Monitor review and regulatory actions.As a DTS team member, you will be a key team player for internal Biostatistics interactions and client engagement on CDISC submission topics, or internal contact for procedural and technical solutions.

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our Biostatistics & Programming (B&P) department are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry leading CDISC expertise and programming leadership through global delivery, consistent quality adherence and scientific insight.

Your responsibilities will include (but are not limited to) the following:

• Creation of specifications, development, validation, and delivery of CDISC SDTM and regulatory deliverables (eCRT Define.xml, SDTM aCRF)
• Analysing and combining data from a variety of sources and structures including virtual trials, wearables, eCOA, etc.
• Generating visualizations (Spotfire), Statistical safety reports (TLFs), safety event notifications and data alerts for study teams.
• Provide consult, analysis, and support across various therapeutic area studies in their CDISC compliance and consistency in mapping.
• Act as programming lead on Phase II-IV studies of moderate to high complexity.
• As programming lead working directly with project team leaders and client representatives and where required to conduct team meetings, develop, and maintain project timelines, assess, and forecast resources, and monitor study budgets.
• Develop instructional training and education materials for the wider B&P community.
• Provide mentorship to junior team members. Education, Experience and Skills required:
  • MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and 4-5+ years of experience
  • In-depth understanding of SAS and, ideally, one other programming language
  • In-depth understanding of relational data base structure and complex data systems
  • Capable of effectively capturing biostatistical metrics
  • Capable of providing quality control review for statistical programming and identifying solutions and process improvements
  • Capable of independently and effectively organizing and managing multiple assignments with challenging timelines
  • Solid project management skills to act as project lead across the most challenging and complex projects
  • Demonstrated leadership, initiative, and motivation
  • Capable of training and mentoring others
  • Fluent in English EEOC:We are an inclusive equal employment opportunity company.We value all people regardless of background, experience and abilities.Below is listed the working environment/requirements for this role:
    Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
    Able to work upright and stationary for typical working hours.
    Ability to use and learn standard office equipment and technology with proficiency.
    Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
    May require travel.(Recruiter will provide more details).
    
    The salary range estimated for this position is $109,000-130,000. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.
    
    We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
    • A choice of national medical and dental plans, and a national vision plan
    • A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Account (HRA) or Health Savings Account (HSA)
    • Tax-advantaged savings and spending accounts and commuter benefits
    • Employee assistance program
    • Paid Time Off, 10 paid holidays annually, 8 hours of volunteer time, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
    • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
      As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
      
      Our 4i Values:
      
      Integrity - Innovation - Intensity - Involvement
      
      If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!
      
      *LI-KF1

Keywords: Thermo Fisher Scientific, Cary , Sr Programmer Analyst- CDISC SDTM (remote), Professions , Morrisville, North Carolina