Director Biostatistics

Location
Emeryville, CA, United States
Posted
Nov 13, 2020
Ref
1036
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
COMPANY DESCRIPTION:

At Santen, we’re innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field—through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.

We are in search of top talent to help us meet our aggressive and important goals.

ABOUT THE POSITION:

The Director of Biostatistics will be responsible for coordinating, implementing and managing the biostatistics and clinical data activities as well as supporting the assigned clinical programs as the Lead Biostatistician. The Director will develop innovative clinical study designs and lead all the effort to perform state of the art statistical analysis in collaboration with clinicians and other project team members from various functional groups at Santen.

This position will closely work with the Head of Global Data Sciences, Global Biomedical Science, Clinical Science, Clinical Operation, Medical Affairs, Marketing and with project managers in providing strategic input to the product development plans, study designs, and product registration filings globally. This position manages and mentors several junior biostatisticians and supports the effort to develop and maintain all standard operating procedures related to statistical analysis, and to implement the CDISC standards. This position is also responsible for the analysis, visualization and reporting of all Clinical data of the assigned clinical programs.

ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Provides strategic input to development programs including filing strategies worldwide, clinical study designs, analytic methods, endpoints that meet both regulatory and scientific requirements
  • Coordinates and manages requests for data formatting, analyses and visualization/representation to support all key global projects in Santen portfolio
  • Manages and mentors FTE and Contractor biostatisticians including consulting biostatisticians and interns as appropriate
  • Work closely and effectively with other group directors within Global Data Science , including Programming and Clinical Data Management
  • Lead company’s statistical analysis activities, such as implementing statistical principles and standards such as CDISC standard, supporting clinical projects, developing innovative study designs and leading all the effort to perform state of the art statistical analysis
  • Make presentations and represent biostatistics to therapeutic leads, senior management, external collaborators and KOLs, FDA meetings, FDA advisory boards [and other Health Authorities], and medical and statistical meetings
  • Serves as statistical representative in the cross-functional teams for the clinical trial planning, executing, and reporting
  • Guides the Biostatistics team members for all planning activities
  • Contributes to the development of Protocol by participating in study design meetings, determining appropriate statistical methodology for data analysis (including definition of endpoints, sample size planning and power calculation, specifications of statistical models and testing procedures, etc.), and drafting the statistical sections of Protocol
  • Drafts data analysis plan documents such as Statistical Analysis Plan and Centralized Monitoring Plan, incorporates comments from other relevant functions, and finalizes the documents
  • Participates in database design meetings to ensure that the eCRF designs comply with the Protocol and capture all data required to support a quality database and planned analyses
  • Specifies an appropriate randomization scheme and reviews pseudo randomization schedule(s)
  • Generates mock-up tables, listings, figures (TLFs) for project deliverables as necessary and incorporates comments from other relevant functions to ensure appropriate presentation of analysis results
  • Reviews the SDTM specification document and generates detailed ADaM specification document based on the SDTM specification document
  • Guides Statistical Programming in preparing for the project deliverables, reviews statistical outputs, and participates in validation of statistical outputs as necessary
  • Prepares oral and written reports to effectively communicate outcomes of clinical trials to the study team, management, regulatory agencies, key opinion leaders, or individual investigators
  • Conducts statistical quality control to ensure the accuracy of analysis results in regulatory documents or publications to be presented in public
  • Collaborates with Clinical Operations, Data Management, and Statistical Programming to perform necessary risk-based statistical monitoring on living database to help improve the site performance and data quality
  • Provides statistical support as needed for reports required by the Data Monitoring Committee
  • Provides statistical support for other functions such as Pharmacovigilance, Medical Affairs, and Marketing
  • Participates in study team meetings and other activities organized to improve operational and statistical analysis procedures
  • Attends meetings and participate in conference calls with regulatory agencies or investigators, presents statistical methodologies and/or outputs at meetings, and responds to statistical questions raised by other attendees
  • Involves in research for innovative statistical methodologies for clinical trials
  • Maintains the version control for statistical documents
  • Attends conferences and job-related trainings as appropriate
  • Ability to determine when to use internal resources or a CRO experience managing outside consultants/CRO’s preferred
  • Other duties may be assigned as needed.

QUALIFICATIONS:

Core competencies, education, and experience:
  • Ph.D. in Biostatistics or Statistics, and 10+ years of experience or MS in the same fields with 12+ years of experience in the pharmaceutical industry ophthalmic pharmaceutical industry experience preferred
  • Thorough knowledge of statistics as it applies to clinical trials
  • Excellent verbal, written, organizational and presentation skills
  • Excellent knowledge of FDA and EMEA statistical guidelines. Submission experience including NDAs/MAAs is a plus
  • Solid understanding of mathematical and statistical principles, including knowledge of methods for handling missing data, longitudinal data analysis, categorical data analysis, multiple comparisons and multiple endpoints, interim analyses, simulation techniques, adaptive designs, and bioinformatics demonstrated proficiency in SAS preferably knowledge of other statistical software is a plus
  • Excellent judgment and problem solving skills in complex situations
  • Excellent negotiation and interpersonal skills
  • Ability to drive change and influence decision making
  • Ability to integrate planning efforts across departments to ensure organizational effectiveness
  • Ability to use competitive intelligence to influence clinical development
  • Ability to articulate the reason behind organizational changes and demonstrate resilience throughout change efforts
  • Ability to set up and influence collaborations with external organizations
  • Management style that delegates to and empowers employees, and fosters teamwork
  • Ability to coach and provide timely and constructive feedback
  • Ability to become an expert in new therapeutic areas, develop an in depth knowledge of the disease and treatments that are available or in development, and ability to apply this knowledge to drug development
  • Demonstrated ability to provide insight into patterns within data which sheds new light on optimal ways in which treatments should be used

WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS:

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.