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Associate Director/Sr. Manager - Statistical Programming

Status: Active
CompanyDenovo Biopharma
LocationSan Diego, CA
Expiration2023-05-12
How to Apply

Applicants who meet one of our vacant position designation criteria should send their resume to hr@denovobiopharma.com, indicating the position they are applying for in the subject heading. Candidates must be authorized to work in the U.S. Can work remotely.

Report to VP of biometrics, this position will provide strategic leadership and programming expertise to Denovo’s clinical development programs across different therapeutic areas. This position will be responsible for CDISC standards with extensive programming capability, he/she will lead and manage external consultants, and work closely with data managers & biostatisticians.

Primary Responsibilities:

  • Participate in CRF design and development of clinical study databases.
  • Provide SAS programming including SAS Macros on TFLs for ongoing clinical trials.  
  • Understand common statistical analysis principles and EDC platforms. 
  • Lead reviewer on terminology and implementation guide on SDTM and ADaM datasets.
  • Work on CRO’s budget proposal from the programming perspective.  
  • Lead reviewer in eCTD documents for regulatory submission package.
  • Provide programming support for ISS/ISE and adhoc analyses.
  • Manage project timelines and deliveries with internal personnel and external teams.
  • Oversee CRO’s and internal statistical programming work.
  • Primary author for Statistical Programming SOPs.

Qualifications:

  • MS or BS in statistics, computer Science, or a related field with at least 8 to 10 years experiences from pharmaceutical and biotech companies or CRO.
  • Hands on experience on statistical programming activities on late phase clinical trials.
  • Experienced in managing CROs and other vendors. 
  • Experienced in NDA and MAA submissions.
  • In-depth knowledge of CDISC standards for SDTM, ADaM, and BIMO requirements.
  • Experience in programming specifications for ISE/ISS, and eCTD submission package.
  • Familiar with FDA and ICH regulations and guidelines.
  • Ability to work on multiple projects simultaneously, and flexible when priorities change.
  • Ability to work independently with strategic initiatives.
  • Collaborate effectively and efficiently with colleagues across other functional areas.
  • Demonstrate great leadership skills.
  • Excellent communication, organizational, and documentation skills.
  1. Clinical Pharmacology, Director/Sr. Director/VP

 

Responsibilities:

  • Provide subject matter expertise in the design, conduct, and reporting of clinical trials
  • Lead clinical pharmacology studies and perform PK and PK/PD analyses
  • Preparation of standalone PK/PD section of Clinical Study Report (CSR), in NDA/BLA submissions
  • Present PK findings and represent clinical pharmacology in cross-functional study team settings, oversee CROs and external service providers, and management of Phase I-III studies
  • Interact with regulatory authorities to ensure the quality and supportiveness of pharmacology study data for regulatory agency review and inquiry

 

Skills:

  • Extensive and strong clinical pharmacology knowledges and research skills, including study design, data retrieval, problem solving and results analysis • Deeply understanding with relevant experience in PK/PD/ADME/BA for Phase I-III clinical studies.
  • Problem-solving skills and the ability to find and employ creative solutions
  • Time management and organizational skills, and attention to detail
  • Leadership experiences and the skills to manage and motivate others
  • Ability to translate pharmacokinetic findings into potential clinical impact is highly desirable
  • Related business development experience and capability is a significant plus.

 

Qualifications:

  • MD, PharmD or PhD degree or equivalent in Pharmaceutics, Pharmacology, Pharmacokinetics, or related scientific fields
  • Minimal 8 years working experience as a clinical pharmacologist in drug development for the pharmaceutical/biotech industry
  • A strong working knowledge of clinical pharmacology and related biological sciences
  • Work in a global operations mode in different time zones, able to travel on business needs

Please note these job descriptions are not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Denovo Biopharma is a privately held biotech company using a novel biomarker solution to personalize drug development.   We acquire drugs which have failed Phase 2/Phase 3 clinical trials, discover novel biomarkers, and reenter late-stage trials.  The core technology of the company is its industry's first platform and algorithm to perform de novo genomic biomarker discovery retrospectively using archived clinical samples. This technology is especially useful for late stage clinical drugs that have completed trials with unsatisfactory efficacy or side effect. By identifying biomarkers correlated to patients' responsiveness to drug candidates retrospectively, our technology enables biotech and pharmaceutical companies to design new clinical trials in targeted patient population to achieve higher efficacy and/or less adverse effects. Our platform can be broadly applied to biomarker discovery in most therapeutic areas, such as oncology and neurological diseases.  Our pipeline is filled with first-in-class drugs from Big Pharma that we are applying our biomarker discovery approach to.  Our lead compound is Enzastaurin, an oncology drug acquired from Eli Lilly.  It is in a global biomarker-guided Phase 3 pivotal study for first-line DLBCL using genetic biomarkers that Denovo successfully discovered.  We have also discovered a novel genetic biomarker for our drug liafensine, for treatment-resistant depression, and plan on starting a Phase 2b study using it this year.  Additional we have six other late-stage drugs that are in earlier stages of biomarker discovery.

We are looking for entrepreneurs who will thrive in our collaborative environment and share our mission to change the future of medicine. 

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