AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women's health. In addition, AMAG seeks to collaborate on and acquire promising therapies at various stages of development, and advance them through the clinical and regulatory process to deliver new treatment options to patients. For additional company information, please visit www.amagpharma.com.
The junior/entry-level Biostatistician will provide biostatistical support for the development and execution of clinical trials, including the coordination of all related areas/activities.
Duties & Responsibilities:
Supports the development of protocols, statistical analysis plans and statistical analysis to meet project objectives.
Supports the development of clinical study reports, INDs, NDAs, annual reports, and scientific publications.
Serves as a contributing member of project teams with cross-functional colleagues responsible for meeting study objectives.
Ensures that projects are completed in a timely and accurate manner.
Conducts briefings and participates in technical meetings for internal and external representatives.
Helps determine the best methods and techniques in design and analysis of complex trials in support of project objectives.
Keeps up to date on current statistical methodologies relating to drug development.
Keeps abreast of current scientific progress and actively develops and maintains relationships with outside experts. Serves as a key liaison by representing the company with outside groups.
Follows regulatory requirements and good clinical practice guidelines.
Supports the statistical needs outside the Medical Development as needed.
Performs statistical analysis and statistical programming using SAS and/or R.
Performs other duties as assigned.
Education & Experience:
M.S. in biostatistics, statistics or related fields with 1 or more years of experience in statistical analysis.
Proficiency with SAS and R.
Excellent knowledge of statistical methodology and concepts.
Excellent verbal and written communication skills and interpersonal skills.
Demonstrates ability to solve complex problems to attain crucial project goals.
Experience of more challenging or higher-value projects
Amag Pharmaceuticals, Inc.