Associate Director, Biostatistics
Category: Scientific & Clinical
Compensation Range: 185000.00 - 210000.00
Job ID: 294975
Date Posted: 02/03/2023
Start Date: 02/06/2023
Associate Director, Biostatistics
Full time permanent
Salary Range $185,000 - $210,000 - commensurate with experience
Plus 20% target annual bonus and full benefits package offered
As an Associate Director, Biostatistics, a typical day might include:
You will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. The incumbent will represent statistical issues in regulatory agency meetings. The incumbent will lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in professional associations, conferences, and publications. As an Associate Director, the incumbent will be responsible for mentoring and overseeing less experienced statisticians, with the potential to manage full-time staff.
This role might be for you if you can:
- Represents Biostatistics at Global Clinical Subteams.
- Interacts with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
- Leads contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc.
- Leads and contributes to process improvement and technical working groups and sets timelines and expectations for the deliverables. Authors new/revised SOPs and contributes to cross-functional EPIC workstreams.
- Evaluates appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.
- Prepares presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies. Co-presents findings to management.
- Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians.
To be considered for this opportunity, you must have the following:
- PhD or equivalent degree in statistics/biostatistics with >6 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >10 years’ experience.
- Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.
- Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment.
- Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills.
- Solid knowledge of statistical analysis methodologies, experimental and clinical trial design
- Expertise in statistical software such as R or SAS is required
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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