About this role
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.
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 You'll 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 You'll Need to Succeed Bachelor's 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. What We Offer The salary range estimated for this position is $70,000 - $90,000. 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 #LI-MB1 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. Join us at Altasciences!