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Statistical Programmer II

Mumbai, Maharashtra, India Date posted 06/07/2019 Job ID 53125BR

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

• Deliver best value and high-quality service.
• Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming Coordinator will:
o Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
o Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
• Monitor project resourcing, project budgets, and identify changes in scope.
• Interact with Sponsors as the key contact with regard to statistical programming issues.
• Provide technical support and advice to the internal team.
• Check own work in an ongoing way to ensure first-time quality.
• Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
• Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
• Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.
• Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.
• Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department.
• Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units.
• Create standard macros and applications to improve the efficiency of the department.
• Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
• Be trained in sponsor WSOP’s and disseminate knowledge to project team members as appropriate.
• Proactively participate in and/or lead process/quality improvement initiatives.
• Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.
• Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
• Maintain and expand local and international regulatory knowledge within the clinical industry.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work
• Provide relevant training and mentorship to staff and project teams.
• Lead and supervise and/or create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.
• Develop mapping specifications for data exports in accordance with applicable standards.

Qualifications

SKILLS:
• Proficiency in SAS.
• Knowledge of the programming and reporting process.
• Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
• Demonstrate ability to learn new systems and function in an evolving technical environment.
• Strong leadership ability.
• Attention to detail.
• Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently.
• Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
• Business/Operational skills that include customer focus, commitment to quality management and problem solving.
• Good business awareness/business development skills (including financial awareness).
• Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
• Work effectively in a quality-focused environment.
• Demonstrate commitment to refine quality processes.
• Effective time management in order to meet daily metrics or team objectives.
• Shows commitment to and performs consistently high quality work..

Education
• Educated to degree level in a relevant discipline and/or equivalent work experience

Language Skills
• Competent in written and oral English.
• Excellent communication skills.

Minimum Work Experience
• Relevant Clinical Trial industry experience.

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