Biostatistician II

About The Role

The Biostatistician II is responsible for having a working knowledge of all related processes with the ability to independently lead a study support analysis and provide high quality documents to support sponsors research programs.

What Youll Do Here

• Follow department and company standard operating procedures (SOPs) forms templates and policies.

• Act as Lead Biostatistician for simple to complex studies and be the central point of contact for the assigned Biostatistics team extended internal project team and the client.

• Provide input for Biostatistics portion of project timelines.

• Review of protocols for simple to complex studies.

• Generate randomization schedules using SAS or randomization specific software.

• Develop and quality control (QC) review statistical analysis for studies of simple to complex including those involving safety data and pharmacokinetic (PK) or pharmacodynamic (PD) endpoints.

• Develop or assist in developing the Statistical Analysis Plans (SAPs) and related table figure and listing (TFL) shells for studies of simple to moderate complexity.

• Development of tables of summary statistics and graphics for clinical aspects of clinical trials.

• Assist in answering deficiency letters from regulatory agencies as required.

• Utilize SAS to create and validate inferential statistical programs and results.

• Perform QC review of analyses and documents prepared by other team members for completeness accuracy consistency and structure.

• Oversee Preclinical projects and work with line manager to direct the activities of Biostatisticians on assigned projects which include reviewing the protocol results of statistical analyses statistical report produced by other Biostatisticians and providing support across all statistical tasks during the lifecycle of the project from protocol to final report.

• Coordinate with internal team to deliver high-quality documents in accordance with the timelines agreed upon.

• May represent Biostatistics in client and inter-departmental meetings.

• Conduct all work in compliance with SOPs Good Clinical Practice (GCP) and all regulatory guidelines.

• Maintain familiarity with client and internal team expectations and produce analyses and documents consistent with these.

• Have awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate TPD FDA European Medicines Agency EMA etc) as well as ICH and GCP procedures.

• May participate or lead departmental or interdepartmental quality improvement initiatives.

• Maintain and participate in the objectives of the department.

• Other duties as assigned.

What Youll Need to Succeed

• Bachelors Degree or higher in Statistics or related field required.

• Minimum of 2 Years of related experience preferred.

• SAS MS Word Excel Outlook MS Teams and Power Point.

• Ability to read and interpret technical documents and industry specific manuals.

• Ability to write advanced reports and correspondence.

• Ability to speak effectively before groups of customers or employees of the organization.

• Bilingual proficiency in French may be required depending on location.

• Excellent verbal and written communication skills.

• Professional attitude and strong interpersonal skills.

• Ability to work well with a multi-disciplinary team of professionals.

• Client-focused approach to work.

• Flexible attitude with respect to work assignments and new learning.

• Ability to prioritize workload.

• Superior attention to detail.

• Understanding of clinical research project life cycle and applicable regulatory guidelines.

• Good computer skills (Microsoft Word Excel and Power Point) and ability to understand and adapt to information technology (IT) systems as needed.

• Moderate SAS programming proficiency.

Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of Biostatistician II including but not limited to for the following reasons:

• The requirement to have study protocols designs and clinical research documents written and documented in English as required by industry regulatory agencies.
• The employee communicates frequently with Altasciences employees across Canada and the United States. As such English is the main language used to correspond between offices.

What We Offer

The salary range estimated for this position is $70000 - $90000. Please note that salaries vary within the range based on factors including but not limited to prior relevant experience skills education certification location as well as internal equity and market data. Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences Benefits Package Includes:

• Health/Dental/Vision Insurance Plans

• 401(k)/RRSP with Employer Match

• Paid Vacation and Holidays

• Paid Sick and Bereavement Leave

• Employee Assistance & Telehealth Programs

Altasciences Incentive Programs Include:

• Training & Development Programs

• Employee Referral Bonus Program

• Annual Performance Review

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