Biostatistician - South Africa

2 days left

Company
Synteract
Location
South Africa
Salary
Competitive
Posted
06 Feb 2021
Closes
08 Mar 2021
Ref
28779-EG
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
.
Senior Biostatistician - Bloemfontein

Office based or remote

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview

The Biostatistician plans and conducts the summaries and analyses of data for assigned clinical studies. Works closely with the Sponsor, clinical team, project manager, data manager, other Biostatisticians, and programmers to analyze and present the data based on Sponsor specifications. Creates, verifies/validates, maintains, and reviews the statistical analysis code and the tables, listings, figures, and analysis outputs for assigned studies in compliance with standard operating procedures and relevant regulatory guidances.

Specific tasks would include:
  • Maintain responsibility for assigned tasks: ensure on-time delivery, communicate the status of tasks to internal teams, provide quality control of work produced by others, and ensure statistical analysis is being done according to specifications.
  • Read and understand the protocol, statistical analysis plan, and other relevant study documentation for assigned studies.
  • Provide sample size calculations and documentation for simple studies.
  • Generate randomization schedules and kit lists.
  • Review case report forms for assigned studies to ensure data is collected appropriately to achieve the analysis defined in the protocol.
  • Contribute to statistical analysis plans and produce mock table and listing shells.
  • Review specifications for derived data sets.
  • Create programming code for inferential analyses, and ensure programming is being done according to Synteract SOPs and Sponsor expectations.
  • Review tables, listings, figures, and analysis output.
  • Perform bibliography research for statistical analysis techniques
  • Maintain responsibility for assigned studies: ensure on-time delivery, communicate the status of studies to internal teams and Sponsors, provide quality control of work produced by others, and ensure statistical analysis is being done according to specifications.
  • Review the protocol, statistical analysis plan, and other relevant study documentation for assigned studies and provide feedback.
  • Provide sample size calculations and documentation for more complex studies.
  • Serve as lead statistician for assigned studies, and coordinate and monitor work assignments of other supporting Biostatisticians.
  • Write statistical analysis plans and produce mock table and listing shells.
  • Work closely with internal teams and Sponsors to ensure high quality, timely deliveries of tables, listings, figures, statistical analyses, and reports.
  • Write statistical reports to summarize study results.
  • Review statistical results sections of clinical study reports.
  • Represent Biostatistics in communication with internal teams and Sponsors Contribute to the protocol for assigned studies by adding to the statistical methods section and providing input on study design issues, endpoint definitions, and sample sizes.
  • Serve as lead statistician for programs of studies and ensure consistency across multiple studies for a single Sponsor.
  • Provide a senior review of statistical analysis plans and mock table and listing shells for other Biostatisticians.
  • Provide a senior review of tables, figures, listings, and analyses for other Biostatisticians.
  • Serve as Independent Reporting Statistician for Data Monitoring Committees.
  • Provide statistical guidance and training for other Synteract Biostatisticians.
  • Participate in on-study and post-study audits.
  • Contribute to the business development process by participating in bid defences.


Degree and Experience:
  • Master's degree or equivalent in statistics, mathematics or related field of study and a minimum of 5 years related experience or equivalent combination of education and experience.

Specific Knowledge:
  • Possesses an intermediate understanding of a wide range of statistical methods relevant to clinical trials.
  • Understands the design, randomization, sample size calculation, conduct, analysis, and reporting of clinical trials.
  • Understands data management, programming, medical writing, and regulatory issues associated with clinical trials.

If you're passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.

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