Associate Director / Director, Biostatistics
Description

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.


Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.


Job Description:

The Associate Director / Director of Biostatistics provides the statistical leadership and

expertise on a study/project team. Be accountable for all statistical aspects of clinical studies,

including the design, monitoring, data analysis, and results reporting. Ensures rigorous

statistical methodology applied in the trials and compliance with good clinical practice. Work

collaboratively with cross-functional team and external vendors to ensure the quality and

timeliness of all the statistical deliveries. Identify and manage the statistical services as needed

to meet the program/study objectives. Manage biostatistical vendor(s) and utilize both internal

and external resources to be adaptive to the fast-changing environments.



Essential Job Functions:

•    Represent the biostatistics function in the study/project team and collaborate with 

the cross-functional team in creating the clinical development plan and developing individual study 

protocol.

•    Serve as the independent biostatistical lead on multiple studies/projects to provide 

the statistical inputs in study design, study conduct and monitoring, data analysis, study results 

presentation and interpretation, clinical study report, and publications.

•    Author/review the statistical analysis plan, review TLF shells, and lead the 

execution.

•    Provide statistical support to the Data Safety Monitoring Board

•    Perform ad-hoc/post-hoc analysis in support of publications/meetings, and 

conferences.

•    Participate in the regulatory activities, including IND, NDA/BLA, etc.

•    Review study Case Report Forms and data management plan to ensure that the analysis 

data are captured appropriately, and participate in the data review to ensure the data quality.

•    Review the SDTM and ADaM programming specifications, and define.xml.

•    Plan and track biostatistics activities, manage timelines and resource use across 

studies/projects. Ensure operational optimization.

•    Participate in establishing and maintaining standards and procedures for 

biostatistics and programming activities.

•    Apply innovative approaches to study design and analysis to modernize drug 

development and improve the efficiency.

•    Oversee vendors providing statistical and programming services to ensure the timely 

deliveries and the quality, and manage the relationship with the vendors.


Qualification:

Required

•    PhD in statistics, biostatistics, or the equivalent with 5+ years of relevant work 

experience in biotech, pharmaceutical or CRO industry. MS in statistics with 8+ years of relevant 

experience.

•    Good knowledge of statistical methodology in design and analysis of clinical trials.

•    Excellent verbal and written communication skills, and ability to work 

collaboratively and independently in a dynamic, cross-functional environment.

•    Able to manage multiple projects simultaneously, to manage conflicting priorities, 

and to be adaptive when priorities change.

Desired

•    Good knowledge of ICH guidelines and regulatory guidance for drug development

•    Good knowledge of statistical programming in SAS and/or R

•    Experience as an independent lead statistician with responsibility for multiple 

studies or projects.

•    Experience working with CROs, and relationship management.

•     Preferably NDA/BLA experience, including eCTD submission.


Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives.  In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.