Director / Senior Director, Biometrics

Location
Working from home
Posted
Jul 15, 2021
Ref
1035
Required Education
Bachelors Degree
Position Type
Full time
Job Title: Director / Senior Director, Biometrics

Schedule: Full-time

Location: Remote

Classification: Salaried, Exempt

Reports to: Chief Medical Officer

Direct Reports:N/A

Position Summary:

The Director/Sr. Director of Biometrics will be accountable for driving and overseeing our biometrics activities. This includes all data management, programming, statistical strategy, and statistical activities to ensure the necessary capabilities and resources are in place to optimize the design, conduct, analysis and interpretation of clinical data for each of Talaris programs.

They will partner closely with functional leaders across the Clinical Development organization, including Medical, Clinical Operations, Regulatory Affairs, Research and others and will represent the Biometrics function on core project teams. They will be accountable for the management of the function including planning and oversight of the budget, providing guidance and oversight to external consultants & CRO staff, and identifying and addressing technology needs or other resource gaps.

Principal Duties and Responsibilities:
  • Responsible for the delivery, integrity and quality of clinical data across Talaris portfolio
  • Performs as core member of the Clinical Development Team and advises team on statistical strategy, on most up-to-date biometrics methodology and tools in clinical drug development
  • Serves as the statistical and data management leader in the design, analysis and interpretation of clinical study data and in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report and other regulatory submission documents or publications, ensuring accuracy and statistical validity
  • Leads data management, programming and statistical activities internally and provides guidance/oversight of CROs/vendors, with hands on approach to ensure timelines and quality of analysis data and statistical output; reviews and approves key data management and statistical vendor deliverables
  • Following CDISC conventions, oversees or performs eCRF design and annotation, database design specifications; develops or oversees CRO generation of data validation specifications (DVS); participates in user acceptance testing (UAT) of the clinical database, including edit check testing, as appropriate
  • Oversees study team in data review; performs data review for quality issues and general data trends, as needed; provides guidance to others on program-level internal data review standards
  • Defines and oversees data transfer specifications for external data sources (labs, ECGs, PK) and transfer of data; reconciles or oversees external data reconciliation with clinical database
  • Provides oversight to ensure data within EDC is of highest quality to support ongoing data reviews as well as interim and final database lock
  • Plans and directs study level analysis and reporting activities (e.g., design of tables, listings, figures)
  • Leads technology-based initiatives to support clinical development with data visualization tools or other technologies
  • Explains statistical concepts in an easy understandable way to non-statisticians and provides adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required; interprets and translates computational results into biologically relevant conclusions and hypotheses; discusses biological questions, problems and outcomes
  • Develops strong and collaborative working relationships with key business stakeholders (e.g., Project Team leaders, Asset Team Leaders, functional heads within Clinical Development, Research and others)
  • Performs other duties as assigned.

Minimum Education, Training, and Experience Required:
  • Ph D. or M.S. in statistics or biostatistics preferred with minimum of 10+ years of experience in the pharmaceutical or biotechnology industry; oncology experience required
  • Management experience with proven capability as a successful leader in a strategic, cross-functional environment
  • Extensive knowledge of clinical trial development and statistical methodology related to trial design and conduct of clinical studies is required
  • Strong knowledge of ICH, FDA, and GCP regulations and guidelines
  • Strong well-rounded technical skills with SAS, CDISC/SDTM, and Adam data models

Additional Qualifications
  • Scientific background and understanding of clinical trials, clinical development operations and regulatory compliance
  • Extensive experience negotiating successfully with health authorities
  • Strong business acumen and critical thinking skills
  • Flexible, well organized, comfortable with ambiguity and works well under pressure

Physical Requirements:
  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift 15 pounds at times.

Benefits:
  • Health insurance
  • Dental insurance
  • Vision insurance
  • Paid time off 25 days
  • Stock Options
  • 401k


Talaris Therapeutics, Inc. (“Talaris”) is a late-clinical stage, publicly traded (Nasdaq Global Market: TALS), biotechnology company that is developing an innovative method of allogenic hematopoietic stem cell transplantation that we believe has the potential to transform the standard of care in sold organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant immune and metabolic disorders. In a ground-breaking, phase 2 study, our lead therapy, FCR001, enabled 70% of living donor kidney transplant recipients to be weaned off all immunosuppression within 12 months of their kidney transplant without rejecting their donated organ. We have followed these patients for an average of over six years since their transplant, and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. We are currently enrolling patients in FREEDOM-1, a randomized, controlled, open-label Phase 3 registration trial in the United States of FCR001 in 120 adult living donor kidney transplant (LDKT) recipients, and in the second half of 2021 we will be initiating FREEDOM-2, in which we will evaluate the potential of FCR001 to induce durable immune tolerance in patients who have previously received a kidney from a living donor, as well as FREEDOM-3 in which we will evaluate the safety and efficacy of FCR001 in adults with a severe form of scleroderma, a debilitating autoimmune disease. We currently have approximately 100 employees and have a corporate office in Boston, MA in addition to our cell processing facility in Louisville, KY.