- Interfacing with the sponsor, collecting requirements, determining timelines/resource allocation of statistical deliverables.
- Participating in the development of study protocols, including participation in study design discussions and sample size calculations.
- Reviewing CRFs and data review guidelines, developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications.
- Authoring Randomization, Sample Size Calculation and Statistical Methods section of protocols.
- Performing statistical analyses and interpreting statistical results.
- Preparing clinical study reports, including abstracts, manuscripts and integrated summaries for submissions (ISS/ISE).
- Responsible for development of ADaM package including authoring QC ADaM specifications; assessing impact of protocol amendments and DB design changes on SAP, SDTM and ADaM package; and reviewing/QC ADaM datasets programmed by STAT team.
- Reviewing draft and production statistical output, responsible for quality and consistency of output across multiple cycles.
- Recommend statistical methodology to analysis of clinical trial data.
- Acting as Biostatistician on DSMBs, SMCs and IDMCs.
- Leading study activities when called upon.
- Trouble-shoot complex statistical issues and make recommendation.
- Utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms.
- Master's degree in statistics or a related discipline. PhD strongly desired.
- 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a Contract Research Organization.
- Therapeutic experience in Oncology, CNS, Medical Affairs, Immunology or orphan drug indications strongly desired.
- Proven experience leading Statistical Projects.
- Solid knowledge and application of CDISC, SDTM and ADaM submissions.
- Strong knowledge of FDA and ICH regulations and guidelines.
- Excellent oral and written English skills.
- Proficiency in Microsoft Office suite (Word, Excel, Power Point);
- Quick learner, good adaptability and versatile;
- Excellent leadership, judgement, soft and problem-solving skills;
- Strong organizational, communication, time management and multi-tasking skills;
- Good knowledge of good clinical practices, and applicable local and international regulations/guidelines.
- Ability to work to tight deadlines while maintaining high standards
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Lead Biostatistician - Toronto, Canada - SCiAN Services
Description
Exceptional opportunity to work with growing and successful CRO
About Scian
SCiAN Services is a Contract Research Organization offering expertise-based services in the Biotechnology/ Pharmaceutical Industry. SCiAN serves well known companies by providing high quality deliverables and superior customer service. For over 34 years we have embraced innovation when offering services in Pharmacovigilance, Biostatistics, Data Management and Custom Database Solutions. SCiAN's therapeutic expertise includes immuno-oncology, gene therapy, CNS, infectious disease, autoimmune diseases and diabetes.
Job Summary
SCiAN Services offers employees exceptional opportunities for growth and exposure within the company itself. In your position, you will be introduced to all areas of expertise ranging from Biostatistics to Data Management to IT. SCiAN's employees learn in a hands-on, personalized environment, and are able to achieve more as a result.
To support the Company's growth, we are seeking to add Lead Biostatistician to our team.
As Lead Biostatistician, you will leverage your knowledge and experience in applying advanced statistical methods and SAS skills to lead or help drive one or more Phase I-IV trials, with a focus on any of the following: Immunology, Early Development, Medical Affairs, Oncology, and Infectious Disease studies. Working collaboratively with the STATs and CDM groups, you will ensure high quality statistical deliverables.
Key Accountabilities:
Qualifications and Experience:
Knowledge and skills:
Candidates must be eligible to work in Canada.
To find out more about SCiAN Services and to review other opportunities, please visit our website at
We thank all interested applicants, however, only those selected for an interview will be contacted.
