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Associate Director, Biostatistics

Position Summary:

Contribute to all biostatistical activities in support of Achaogen’s clinical and non-clinical programs. This includes, but is not limited to, biostatistics strategy and function; statistical lead in new or ongoing clinical trials; biostatistics representative on cross-functional study teams; support to the Director of Biostatistics in the management and direction of the company’s biostatistical activities.

Essential Functions:

  • Serve as biostatistics lead on one or more clinical trials or programs, providing support in clinical development planning, study design, development of study documents (e.g. protocol, statistical analysis plan, data monitoring committee charter, etc), statistical analysis planning, and data interpretation.
  • Oversee the completion of analytical plans, ensure that statistical methods are sound, and work to establish a Biometrics timeline and review cycle such that analysis outputs are delivered on time and to Achaogen’s quality standards in a cross-functional team setting
  • Support preparations for potential plazomicin anti-infective drugs advisory committee (AIDAC) presentation. 
  • Collaborate with the Director of Biostatistics in the management of resources and departmental budget.
  • Collaborate with QA and department colleagues to develop and maintain biostatistics Standard Operating Procedures.
  • Represent statistical function on clinical programs to the wider company, Health Authorities and KOLs, as required. 
  • Ensure biostatistics activities are conducted in accordance with GCP, internal SOPs and meet all regulatory requirements.
  • Work collaboratively with key functions: Clinical, Data Management and Statistical Programming on deliverables, timelines, process improvements and other areas as appropriate.

Preferred Experience and Education:

  • Minimum of 8 years relevant experience in the pharmaceutical or biotechnology industry.
  • Comprehensive knowledge of statistical theory and methods.
  • Demonstrated success in the design and analysis of clinical trials as well as familiarity with non-clinical experiments (especially microbiological): statistical considerations, design, and analysis.
  • Relevant involvement in regulatory filing / approval of NDAs / BLAs or equivalent.
  • Experience preparing analysis programs for clinical trials phases I-III.
  • Working knowledge of statistical analysis plans including the report outline, mockup tables, graphs, and data listings.
  • Experience in representing biostatistics in cross-functional teams, and presenting to program core teams as needed.
  • Experience in implementing industry data standards such as CDASH, SDTM, and ADaM.
  • Proficiency in relevant statistical analysis software systems such a SAS, R, Spotfire.
  • Knowledge of infectious disease clinical trials design, endpoints, and analysis populations is a significant plus.

 Preferred Education:

  • PhD or MS/MA/MPH in Biostatistics or a related field; MS/MA/MPH is minimum

Preferred Additional Skills:

  • Must have sound knowledge of statistical applications for clinical trials and SAS programming.
  • Excellent leadership, management, collaboration, communication, and decision-making skills.
  • Outstanding written and verbal communication skills including presentation effectiveness.
  • Excellent team interaction skills along with demonstrated ability to lead and influence others.
  • Independent, self-motivated, innovative, and creative thinker.
  • Ability to demonstrate effective leadership in ambiguous and frequently changing situations.
  • Proven ability to positively impact company culture and demonstrate flexibility in fast paced environment.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
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