Principal Statistician

4 months ago

Bengaluru, India Veramed Full time

Veramed is a specialist contract research organisation (CRO) to the pharmaceutical industry, focused on delivering high quality statistics and programming for the reporting of Phase I-IV clinical trials across a variety of therapeutic areas. The projects and clients we work with provide a varied and exciting challenge; this in turn enables us to help develop and enhance our employees’ capabilities and gives opportunities for growth.


Location: Bangalore / Hyderabad / Remote


The role of the Principal Statistician is to provide statistical support to the statistics and programming department across a range of projects, clients and therapeutic areas.


The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.


Technical

  • Perform technical and consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs
  • Author simple and complex study SAP and TFL shells
  • Author and review simple and complex dataset standards
  • Perform data checks and data exploration (e.g. using frequencies, histograms)
  • Identify data and standards issues and resolve or escalate as appropriate
  • Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications, applying good programming practice
  • Application of complex statistical techniques (e.g. mixed effects, non-linear modelling, Bayesian, advanced survival), model checking and interpretation
  • Perform literature review and ability to extract and collate relevant information and data from external papers as needed
  • Identify and implement appropriate sample size method using software or simulations
  • Support study team in providing study design options
  • Review of project management related documents
  • Maintain study master file documents and any other documents that are required to be audit ready


General

  • Communicate rationale and mechanics of study designs & analysis methods
  • Lead internal and client study team meetings effectively
  • Present study updates internally and at client meetings
  • Share scientific, technical and practical knowledge within the team and with colleagues
  • Perform work in full compliance with applicable internal and client policies, procedures, processes and training
  • Build effective collaborative working relationships with internal and client team members
  • Seek opportunities to develop innovative ideas, sharing when appropriate
  • Line management or mentorship of more junior team members
  • Contribution to development of internal training materials
  • Contribution to internal process improvement initiatives


Requirements

  • MSc or PhD in Statistics/Biostatistics (or equivalent)
  • At least 7 years of relevant industry experience
  • Understanding of clinical drug development process, relevant disease areas, endpoints and different study designs
  • Awareness of industry and project standards & ICH guidelines
  • Excellent verbal and written communication skills
  • Interpersonal/teamwork skills for effective interactions
  • Proficiency in data handling using SAS or other statistical software (e.g. R)
  • Self-management skills with a focus on results for timely and accurate completion of competing deliverables
  • Demonstrated problem solving ability and attention to detail
  • Ability to work independently and as part of a team


If you have a passion for contributing to high quality deliverables, thrive when working closely with team members of all levels of experience and want to work for a company where you truly feel you can add value, this role could be for you. Apply now.


As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.

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