Principal Biostatistician (North & South America)
At a glance
Senior Data Science role at bioforum. Full-time.
Pay not stated Data Science salary
dataroles summary, based on the employer's posting.
What you'll do
- Lead the statistical work on clinical trials, owning their analysis requirements and advising on study design and methods
- Guide customers on statistical needs and questions during trial planning and execution
- Write or review protocol statistics sections, analysis plans, and clinical study report results
- Check TLF shells, dataset specifications, and programmers’ statistical outputs; build SAS programs for study results
- Mentor junior statisticians and contribute to department efforts to improve quality and efficiency
What you bring
- At least eight years working as a biostatistician on clinical trials
- An honours degree in a statistics-related subject; a master’s or PhD is an advantage
- Strong knowledge of advanced methods for clinical trial analysis and GCP, ICH E9, and regulatory guidance
- Experience leading studies or projects and working directly with customers
Who this fits
This senior role suits an experienced clinical-trial biostatistician who can lead statistical work, advise customers, and mentor junior colleagues. You must be based in North America, including Canada, or South America, and the role is remote.
From the employer
The Bioforum Biometrics department is growing, and we have an opportunity for an experienced biostatistician to join our group. This position is for candidates located in either North America (including Canada) or South America (remote).
Purpose: Works alongside the Director: Biostatistics to provide biostatistical support and services related to clinical trials. Act as Statistical Lead on clinical trials.
Required skills:
- Minimum 8 years’ experience as a biostatistician working on clinical trials.
- Knowledge of advanced statistical methodology used in the analysis of clinical trial data
- In-depth knowledge of industry guidelines (GCP, ICH E9, regulatory guidelines)
- Study / Project lead / Customer interaction experience
- Attention to detail.
- Excellent communication skills.
- An Honours degree (a Masters degree / Ph.D will be an advantage) in a statistics related field.
- Experience interacting with a regulatory agency will be an advantage
Duties will include:
- Ownership of the statistical aspects and requirements on clinical trials done by Bioforum.
- Provide guidance on study designs and statistical methodology as appropriate.
- Interact with the customer and provide guidance / input on the statistical requirements and queries in the planning and during the conduct of the trial.
- Statistical review and preparation of documentation, including the statistics section of the study protocol, Statistical Analysis Plan, and statistical sections / results interpretation of Clinical Study Reports (CSRs).
- Provide training/mentorship to junior statisticians.
- Review Table, Listing and Figure (TLF) shells associated with the study SAP.
- Review ADaM and/or derived dataset specifications as required.
- Development of SAS programs for study TLFs focussing on efficacy and/or advanced statistical methodology.
- Review statistical output produced by the statistical programming team.
- Contribute to department wide initiatives to improve quality and efficiency.
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