Director, Biostatistics Jobs in Redwood City, CA at Allakos
Title: Director, Biostatistics
Location: Redwood City, CA
Salary: $150K – $200K*
Category: Pharmaceuticals & Biotech
The Director, Biostatistics will support the Allakos Clinical Development and Medical Affairs/Bioanalytics teams by managing Biostatistics activities and personnel in the design and implementation of clinical studies.
The position requires a highly-motivated individual to work collaboratively in a cross-functional team environment. This individual will play a key role in ensuring accurate, high quality clinical trial data in a fast-paced, start-up biotech environment. Overall responsibilities will include oversight of biostatistics activities from study start-up through study closure in support of trial objectives, regulatory submissions, publication activities and corporate goals. This position reports to the Sr. Vice President, Clinical Operations.
Serves as the primary overseer/”point person” for Allakos biostatistics activities.
Works with clinical, data management and regulatory teams to develop Study Protocols and Statistical Analysis Plans.
Collaborates with clinical and data management team in the design and implementation of EDC systems to support the Allakos clinical program.
Collaborates in the development, implementation and integration of IRT systems, as applicable.
Produces Clinical Study Report in collaboration with Medical Writing in the production of Clinical Study Reports.
Assists, as needed, with cross-functional User Acceptance Testing (UAT) of integrated clinical databases and associated clinical data systems.
Assists in the development of data quality and management plans.
Ensures biostatistics timelines for assigned projects are met, up to and including the timely delivery of Tables, Listings and Figures for individual studies.
Oversees production of quality data deliverables for assigned protocols to support regulatory submissions and due diligence activities. Assists the Medical Affairs and Bioanalytics in providing deliverables to support medical affairs and publication needs.
Participates in the review of clinical and regulatory documents, as needed, to assure data integrity and quality.
Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions.
Supports compliance with industry quality standards, guidelines and procedures. Participates in the development of department SOPs and standards/templates with focus on CDISC implementation.
Assists with the selection, development and evaluation of personnel and vendors to ensure the efficient operation of the function.
Oversees projects that have been engaged with Contract Research Organizations (CROs), as well leads and manages internal projects.
Participates in providing suitable input into corporate and department budget process and management.
Other data management related duties as assigned.
QUALIFICATIONS & EXPERTISE:
Bachelor’s degree preferably in Life Sciences, Statistics or Mathematics; an equivalent combination of education and applicable job experience may be considered. A minimum of 5 years progressively responsible experience in biostatistics and/or clinical data management in the pharmaceutical/biotechnology/CRO setting with 2 years’ experience in a leadership role.
MS or PhD in Statistics/Biostatistics preferred
Previous experience managing projects in a Biostatistics/Bioanalytics group, with exposure to the complete Biostatistics cycle (Start-Up, Conduct, …