- Follows department and company standard operating procedures (SOPs), forms, templates and policies.
- Provides feedback and update these guidelines as needed.
- Manages deliveries and ensures assigned studies or clinical programs achieve timelines and quality per contractual agreements and sponsor and company expectations.
- Provides guidance for all statistical and/or programming aspects of studies such as design, randomization, statistical analysis plan, analysis, data presentation, and interpretation of results.
- Manages assignment of Lead Biostatisticians and Lead Statistical Programmers to studies and clinical programs.
- Identifies project risks and issues and actively participates in escalation and resolution.
- Proactively works with cross-functional team members and other departments to anticipate client needs and ensure common understanding and commitment/alignment. ·
- Attends study team meetings and provides feedback regarding timelines and issue resolution as needed.
- Maintains compliance and ensures departmental awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], Food and Drug Administration [FDA], European Medicines Agency [EMA], etc) as well as the International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) procedures.
- Maintains strong knowledge of Clinical Data Interchange Standards Consortium (CDISC) requirements to meet regulatory standards.
- Develops quality processes and maintains corresponding documentation (SOPs and Work Instructions [WIs]).
- Leads and participates in intradepartmental or interdepartmental process and quality improvement initiatives. Including both technological and process improvements leading to improved deliverable quality and department efficiency.
- Collaboratively develops training plans and training for all roles within the Biostatistics department.
- Supports management in evaluating staffing needs
- Master's Degree in statistics, programming, health-related sciences, or relevant field
- 7+ years of industry- or contract research organization (CRO)-related Biostatistics and/or SAS Programming experience.
- 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.
- Solution-focus and ability to creatively solve problems and resolve issues.
- Flexible attitude with respect to work assignments and new learning.
- Ability to take initiative and use sound judgment.
- Ability to acquire and apply knowledge quickly.
- Flexible attitude and an ability to effectively prioritize.
- Proven history of continuous improvement.
- Understanding of clinical research, statistical principles, drug development process, and applicable regulatory guidelines.
- Strong technical aptitude and expertise in current statistical analysis principles. · Working knowledge of SAS programming and CDISC implementation.
- Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems.
- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
- Training & Development Programs
- Employee Referral Bonus Program
- Annual Performance Reviews
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Manager, Biostatistics - Laval, QC, Canada - Altasciences Co.
Description
Thursday, May 16, 2024
Your New Company
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences.
Your Role:
The Manager, Biostatistics is responsible for leading the team of Biostatisticians and/or Statistical Programmers in the design, analysis, and interpretation of clinical study data ensuring efficient production of high-quality client and internal deliverables. They take accountability for overall planning, organization, and coordination of Biostatistics and/or SAS programming support for all assigned studies and programs. In addition, the Manager, Biostatistics is responsible for employee recruitment, training, and retention as well as collaboration to meet department quality and financial goals.
What you'll do here:
What you'll need to succeed:
What We Offer
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:
MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Altasciences warrants adherence to applicable labor laws, including non-use of forced, prison or child labor, in violation of US and Canada laws, in its operations or supply chain.
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