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Associate Director/Director, Biometrics

Cambridge, MA · Science/Research
COMPANY OVERVIEW:
 
Synlogic™ is bringing the transformative potential of synthetic biology to medicine.  We are building the premier Synthetic Biology platform to engineer bacterial Synthetic Biotic medicines which benefit patients in new ways
 
Using a platform that leverages reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic medicines that target validated underlying biology to treat disease in new ways.
 
Synlogic’s proprietary pipeline includes Synthetic Biotics for the treatment of metabolic disorders including Phenylketonuria and Enteric Hyperoxaluria. The company is also building a portfolio of partner-able assets in immunology and oncology.
 
We combine Human Logic and Science Logic to drive meaningful work, careers, and life at Synlogic.  We foster a people-focused environment grounded in:  Compassion, Transparency, Collaboration & Fun, while adopting a patient-focused mindset to inspire:  Innovation, Integrity, High Performance, and life -changing Results.
 
We continue to build and enhance our organization.  If you want a settled environment, pursuing a well-walked path then this environment is probably not for you.  If you want to challenge yourself and build your career while bringing the transformative potential of synthetic biology to patients then we’d love to hear from you.
 
POSITION SUMMARY:

The Director of Biometrics oversees all data management and statistics activities for clinical programs to ensure timely and accurate delivery of statistical designs, CRFs, database locks, analyses, reports, & regulatory submissions and independently provides strategic statistical input to drug development, including feasibility assessments, development plans, complex study designs, interpretations, and follow up. Works closely with the Clinical Development team, including Medical, Clinical Operations, and Regulatory functions to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data. Represents Biometrics in project teams on all applicable operational and strategic decisions related to assigned projects. This individual is also accountable for the production of biometrics deliverables, managing a team of internal and external data managers and statisticians, and statistical programming resources, and biometrics vendors.

KEY ACCOUNTABILITIES/DUTIES:
 
The Associate Director, Biometrics will be responsible for a broad scope of varying activities to support ongoing clinical programs and corporate goals. Primary responsibilities for this position include, but are not limited to:
  • Provides statistical and associated biometric leadership and support for all activities related to clinical development
  • Applies innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design, and/or Bayesian approaches)
  • Ensures accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents
  • Leads and manages external data management, biostatistics, and programming resources
  • Manages Biometrics vendors from vendor selection through study close out, including, the design and development of eCRFs, CCGs, edit checks, DMPs, tracking metrics, data review/cleaning, and database lock as well as dataset programing, SAP development, TLF programing, and delivery of stats outputs.
  • Leads ongoing data cleaning activities including management of outsourced data cleaning activities as well as internal data review efforts.
  • Responsible for providing Biometrics leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
  • Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program
  • Addresses regulatory submission issues within Biometrics and with other related departments.
  • Ensures that applicable study documentation is maintained in accordance with applicable regulations, industry accepted standards, and internal SOPs.
  • Develops SOPs, work instructions, and standardized forms to define Biometrics processes within a small but growing team.
  • Maintains working knowledge and experience with applicable regulations as well as familiarity with relevant clinical data management systems and industry wide coding dictionaries (e.g., MedDRA).
  • Collaborates with Clinical Operations to ensure the Clinical Trial Master File (cTMF) is maintained appropriately throughout the trial.
QUALIFICATIONS & EXPERIENCES:
  • PhD in Statistics and at least 5 years of relevant biotechnology/pharmaceutical experience or an MSc in Statistics and at least 7 years of relevant biotechnology/pharmaceutical experience
  • Comprehensive knowledge of statistical methodology in design and analysis of clinical trials, including Bayesian modeling and adaptive design
  • Comprehensive experience with designing CRFs and databases as well as coding
  • Regulatory requirements relating to clinical development of drugs and biologics
  • BLA/NDA experience including eCTD submissions is preferred
  • Working knowledge of major statistical software programs, including SAS
  • Knowledge of CDISC requirements for SDTM and ADaM
  • Excellent written, interpersonal, and oral communication skills
  • Must be flexible, well-organized, and can work well under pressure
VALUES & BEHAVIORS

We are at our best when we combine Human Logic and Science Logic to build great teams and deliver outstanding results.  Our 6 values of Compassion, Fun, Trust & Respect, Innovation, Integrity and Results are central to our organization.
 
Synlogic is committed to creating a diverse and inclusive environment and is proud to be an equal opportunity employer, embracing diversity in all forms.  Synlogic hires, trains, compensates and promotes talented Synlogicians regardless of age, color, disability, gender, gender identity or expression, genetics, national origin, race, religion, sexual orientation, veteran status, and other protected statuses as required by the laws and cultures of the geographies in which we operate.  We believe in lifting others both inside and outside of the company, ensuring all of our community has access to opportunities and innovative therapies. 
 
Our compassion for patients is the engine that drives our innovation and motivates our sense of urgency; always remembering that patients are waiting.  Our compassion for each other creates a safe environment for continuous risk taking and personal development – facilitating a rapidly moving, fast-paced environment.   We connect with our colleagues by having fun together. 
 
We take our work seriously and value integrity in producing the highest quality work.  We trust each other, respecting all ideas and driving accountability to generate the best results for our patients and team.  We encourage openness, direct feedback and transparency in decision-making to enable an inclusive, nimble environment.   
 
We seek individuals who exemplify these behaviors and who encourage others to do the same.   
 
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