Careers

Director, Biostatistics – Job #1040

FUNCTION: Medical Affairs

LOCATION: Redwood City, CA

Position Summary:

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.

Primary Responsibilities: 

 You will:

  • 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. 

Must possess:

  • 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, Close-Out, Analysis, Submission)
  • Experience and understanding of ICH and GCP
  • Experience with Electronic Data Capture (EDC) and IRT systems
  • Knowledge of medical terminology
  • Knowledge of coding dictionaries (Medical Dictionary for Regulatory Activities -MedDRA, WHO Drug)
  • Excellent verbal and written communication skills as well as interpersonal and organizational skills
  • Proficiency in MS Office applications
  • Proficiency with data management systems and knowledge and understanding of supporting technologies (e.g., EDC, IRT, ePRO, SAS) and industry standards (e.g., CDISC)
  • Self-sufficient and able to work with minimal oversight.
  • Demonstrated skill at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines.  Able to earn and foster cooperation with and of others.
  • Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals.  Able to make and prioritize process and resource decisions based on overall team needs.
  • Willingness and ability to travel as required.
     

This position is located in the Allakos corporate office in Redwood City, CA

The salary is competitive and commensurate with experience and qualifications.

Interested applicants please send resume to careers@allakos.com​ and job #1040
 

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.