Biostatistics Manager

Location
Emeryville, CA, United States
Posted
Jun 03, 2021
Ref
1103
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 Biostatistics Manager will be responsible for implementing and managing the biostatistics and clinical data activities, support clinical projects, develop innovative study designs and perform state of the art statistical analysis in collaboration with clinicians and other project team members from various functional groups for assigned clinical programs. The position may also contribute data mining and application of machine learning methods for clinical data, real world data, and digital data. Regarding clinical development the job requirements of this position include providing strategic input to development programs such as filing strategies worldwide, study design, analytic methods, endpoints that meet both regulatory and scientific requirements. Dependent upon program size might manage and mentor other biostatisticians. The successful applicant will collaborate closely with other functional areas within the company (Statistical Programming, Clinical Data Management, Clinical Development, Translational Research, Global Drug Safety, Regulatory and Project Management, etc.), and make presentations and represent biostatistics to therapeutic area leads, senior management, external collaborators and thought leaders, health authorities.

ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Work with Biometrics Director to develop and monitor the department strategic direction and its alignment with company strategies
  • Monitor and understands the impact of industry and company strategies on the Biometrics organization and deliverables
  • Develop and maintain all biostatistics related SOPs and guideline documents
  • Participate in new drug development programs as a Subject Matter Expert (SME) in statistics area.
  • Contribute to protocol development by choosing an appropriate study design and statistical methodology, defining end points, calculating necessary sample size to achieve a pre-specified power and writing the statistical section of the protocol
  • Apply and develop innovative trial designs, including Bayesian methods
  • Develop and review the Statistical analyses plan
  • Review CRFs to ensure their design meets the protocol criteria and captures all data required to support a quality database and planned analysis
  • Generate and review randomization schedule (s)
  • Guide the biometrics team members for all planning activities
  • Participate in project teams as biostatistics representative
  • Perform plausibility checks on data and take appropriate action to handle implausible values during analysis
  • Support generation and review of tables, listings, figures to ensure accurate and appropriate analysis and results for clinical studies
  • Ensure the quality of data and accuracy of analyses in regulatory submissions (eg, CSR) or publications
  • Conduct and participate in validation of project deliverables as necessary
  • Perform statistical analysis and prepare corresponding sections of the Clinical Study Report
  • Provide statistical support for any presentations and publications
  • Modeling and simulation to guide design and clinical development decisions and choices
  • Participate in Clinical Trial Team meetings and in activities organized to improve operational and statistical analysis procedures
  • Attend meetings and participate in conference calls with regulatory agencies present statistical analyses at meetings or conference calls; respond to statistical questions raised by regulatory agencies
  • Provide advice and support as requested for Project Management and Business Development
  • Keep abreast of literature/advancements in statistics/science/medicine/technology in own and related fields of the drug development program
  • Contribute to external statistical community through presentations, publications, and service in cross-industry initiatives
  • If applicable, contribute and lead data mining and data sciences activities, including incorporation of novel data types, to inform clinical trial design, reverse translation, and clinical development decision-making

QUALIFICATIONS:
  • Ph.D. in Biostatistics or Statistics with 4+ years of experience or MS in the same fields with 6+ years of experience in the pharmaceutical industry
  • Excellent oral and written communication skills
  • Excellent knowledge of FDA and EMEA statistical guidelines.
  • Solid understanding of mathematical and statistical principles, including Bayesian methods, 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 and R
  • Solid understanding of biomarkers and impact on clinical designs
  • Data science and machine learning experience on large datasets, including real-world datasets, with applications to clinical development or medical affairs
  • 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 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