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Senior Statistical Programmer

Bengaluru, Karnataka, India Date posted 08/23/2019 Job ID 54651BR

As a member of Parexel’s Statistical Programming group, you will be heavily involved in leading trials to successful completion, working in close collaboration with sponsor teams, and Parexel teams in differing locations. Depending on your career goals, you will be provided the opportunity to be exposed to a variety of different sponsors, products and therapeutic areas, or choose to focus your career on working with a specific sponsor and gaining in depth knowledge of a specific therapeutic area and compound.

You will become a part of a team with an inherent breadth of knowledge and expertise in small, single center Investigator studies to multi-site, multi-national trials in Phases I to IV of clinical development, as well as observational studies. From initial planning meetings at the study design stage through to implementation and execution, our team of skilled statistical programmers will employ industry-accepted statistical tools and techniques, as well as innovative consulting, to provide the quality and efficiency of projects.

Parexel develops and delivers cost effective, high-quality training programs for those employees that are directly involved with sponsor functional partnerships to ensure that our statistical programmers can quickly step in to make significant contributions to the success of a study. In addition, you will receive the opportunity to shape your development through quarterly conversations with your manager.

  • Full Time
  • Level: Mid
  • Travel: Minimal
  • Glassdoor Rating 3.5

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Team player
  • Tech-Savvy
  • Communicator
  • Proactive
  • Detail-oriented
  • Analytical
  • "I have learned a great deal and developed my expertise. The management team here is open and honest and it is refreshing to be treated with a high degree of trust and flexibility. I have been fortunate to work on a wide variety of projects and partnerships and the work is always interesting."

    Richard – Principal Statistical Programmer
  • "My experience so far with Parexel has been great! I had initially started at Parexel as an Independent Consultant but was then presented with a full time job opportunity to really become a part of this fascinating company. I have enjoyed the flexibility to be able to orchestrate a good work/life balance, as well as learn from so many experts in consulting arena and really have a hands-on role with every day bringing a new but exciting challenge."

    Aqip – Consultant
  • "I was offered an incredible opportunity to continue my career in regulatory affairs without relocating 1,000 miles away and making major life changes. Parexel is an innovative, growing company which offers much needed flexibility and opportunities for professional growth."

    Blaine – Consultant
  • "Parexel is a very large organization and holds a top position amongst the different companies engaged in the Consulting business. It can offer many opportunities for development and career progression. Also the diversity of projects can offer a great expansion of knowledge in many areas of the Regulatory Affairs arena. Last (but not least), Parexel offers a variety of rewards to the employees (bonus scheme, benefits etc)."

    Giannis – Consultant
  • "Parexel is a CRO that I had always inspired to join because of the variety of knowledge, experts, culture, flexibility and exposure to be client facing as well as to use my technical knowledge all under a professional and diligent environment. I believe it has provided me the right platform to grow both professionally and individually with the opportunities to present my views and to dialogue with colleagues and clients with all but positive outcomes."

    Aqip – Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Development

    Opportunity to learn and grow through a performance and development goal-setting program.

  • Health and Wellness

    Health and wellness programs, and a wide range of therapeutic areas and medical devices.

  • Variety

    Opportunity to work on a wide range of therapeutic areas and medical devices.

Responsibilities

Maintain all supporting documentation for studies in accordance
with SOPs/Guidelines to ensure traceability and regulatory
compliance.
• Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other
applicable local and international regulations, and participate in
internal/external audits and regulatory inspections as required.
• Proactively participate in and/or lead process/quality improvement
initiatives.
• Provide consultancy to internal and external sponsors with regard
to statistical programming tasks.
• Represent PAREXEL at sponsor marketing and technical meetings.
• Understand regulatory requirements concerning industry technical
standards (e.g. CDISC, 21 CFR Part 11, and electronic
submissions).
Deliver best value and high quality service.
• Check own work in an ongoing way to ensure first-time quality.
Use efficient programming techniques to produce/QC derived
datasets (e.g. SDTM, ADaM), tables, figures, and data listings.
• Produce/QC dataset specifications and other process supporting
documents and submission documentation.
• Ensure quality control (QC) is performed on all process and
technical activities related to derived dataset, table, data listing, and
figure programming in accordance with corporate quality standards,
SOPs/Guidelines, ICH-GCP, and/or other international regulatory
requirements.
Maintain all supporting documentation for studies in accordance
with SOPs/Guidelines to ensure traceability and regulatory
compliance.
• Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other
applicable local and international regulations, and participate in
internal/external audits and regulatory inspections as required.
• Proactively participate in and/or lead process/quality improvement
initiatives.
• Provide consultancy to internal and external sponsors with regard
to statistical programming tasks.
• Represent PAREXEL at sponsor marketing and technical meetings.
• Understand regulatory requirements concerning industry technical
standards (e.g.CDISC, 21 CFR Part 11, and electronic
submissions).

Qualifications

Excellent analytical skills.
• Proficiency in SAS.
• Extensive knowledge and understanding of the programming and reporting process.
• Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international
regulations such as 21 CFR Part 11.
• Ability to learn new systems and function in an evolving technical environment.
• Strong project management skills.
• Strong organizational skills, ability to manage competing priorities, and flexibility to change.
• Attention to detail.
• Ability to successfully lead a global team.
• Work effectively in a quality-focused environment.
• Effective time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.
• Business/operational skills that include customer focus, commitment to quality management, and
problem solving.
• Demonstrate commitment to refine quality processes.
• Good presentation skills.
• Good business awareness/business development skills (including financial awareness).
Educated to degree level in a relevant discipline and/or equivalent work experience.

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