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Senior Manager / Associate Director, Statistical Programming

Position Summary:

Responsible for hands-on support of statistical programming activities for clinical and non-clinical programs. This includes, but is not limited to, programmatic generation and documentation of tabulation and analysis datasets (per current cCDISC standards) and formal deliverables to be included in all regulatory filings, responsibility for the accuracy and reliability of produced results, ensuring that validation policies including documentation are adhered to for all generated deliverables, and oversight of programming consultants and/or contractors to support deliverables as applicable. Provides input for technical and process solutions for Statistical Programming function.

 

Essential Functions:

  • Provide high quality and accurate analysis outputs and supporting datasets that are delivered on time, on budget, and to Achaogen’s quality standards whether for production or validation programming.
  • Ensure all statistical programming activities are conducted in accordance with GCP, internal SOPs and meet all regulatory requirements.
  • Document data and programming information in accordance to Standard Operating Procedures (SOPs) and guidelines.
  • As applicable, provide oversight in the activities of internal and/or external SAS consultants and contractors, ensuring that analysis outputs are delivered on time, on budget, and to Achaogen's quality standards.
  • Able to develop, modify and complete CDISC specification for both SDTM domains & ADaM datasets, including adherence to CDISC guidelines.
  • Able to receive TFL mocks from Study Biostatistician and add programming instructions to expedite tasks such as source dataset, relevant subsets and other detail as needed.
  • Considers strategies (programmatic or process) that will allow for consistency or continuity of subsequent tasks (e.g., multiple studies or to integrated multiple studies).
  • Recommends technical solutions that can be used or developed to increase efficiency of project work, may assist with development of study or department level macro (as deemed appropriate).
  • Able to debug and resolve issues related to other programmers’ code and communicate issues with system macros to Director of Programming.
  • Analytical and solution driven mind-set. Uses independent data exploration to ensure data fits together as defined by a study’s schedule of assessments, applies this quality to both production and validation programming.

 

Preferred Experience and Education:

  • B.S./M.S. plus minimum 5-9 years relevant experience in the pharmaceutical or biotechnology industry.   
  • Knowledge of FDA ICH guidelines.
  • Comprehensive knowledge of SAS and experience with other relevant statistical analysis software systems (e.g., R, S-Plus).
  • Ability to adhere to timelines and communicate proactively for any compromise to delivering within timelines.
  • Working knowledge of statistical analysis plans including the report outline, mockup tables, graphs, and data listings.
  • Comprehensive experience implementing CDISC standards with hand-on programming of SDTM and ADaM.
  • Experience in working with/oversight/management of biostatistical services provided by CROs.
  • Able to build strong working relationships with appropriate personnel in other functional groups within and outside of the Biometrics organization.
  • Knowledge of infectious disease clinical trial design and analysis population derivations is a plus.
  • Relevant involvement in support of regulatory filing/approval of NDAs/BLAs or equivalent a plus.

 

Preferred Additional Skills:

  • Sound knowledge of statistical applications for clinical trials and SAS programming.
  • Prior experience in providing programmatic support for manual evaluability or outcome adjudication processes.
  • Experience with informal data visualization and review software (e.g. Spotfire, JReview).
  • Strong written, verbal communication and relationship skills including experience with managing external vendors and / or programming contractors.
  • Excellent interpersonal and organizational skills.
  • Ability to work both independently and in a cross-functional team environment.
  • Detail-oriented and have an in-depth understanding of industry trends.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.

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