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Director Statistical Programming

Employer
Avidity Biosciences
Location
San Diego, California
Start date
Aug 25, 2021

View more

Discipline
Information Technology, Bioinformatics
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach

Job Details

Company Overview

 Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.

Job Summary

The Director of Statistical Programming will be responsible for building the statistical programming group, driving technical and process excellence and ensuring compliance with regulatory, corporate and departmental requirements and policies.  The Director of Statistical Programming will provide oversight of CRO statistical programming activities and collaborate closely with other functions in Development and Biometrics. The Director of Statistical Programming will also provide an expert-level hands-on support and technical leadership to all clinical development programs and regulatory submissions. This position will report to the Vice President of Development Strategy and Biometrics.

Essential Duties and Responsibilities
  • Build the statistical programming group and set up SOPs, processes and infrastructure for operational excellence
  • Responsible for resource planning and vendor selection/management regarding biometrics related study activities and documentation
  • Serve as statistical programming representative in study management teams and related regulatory interactions
  • Collaborate with biometrics, clinical development, clinical pharmacology and biomarker teams in building Avidity data and analysis standard
  • Oversee and ensure quality of all statistical programming deliverables
  • Review study protocol, CRF, SAP, DTAs, TFL shell and other study documentations
  • Perform/review/QC TFL production to ensure quality and accuracy
  • Conduct exploratory analyses of existing data, and ongoing data query and review
  • Lead statistical programming deliverables for regulatory submissions
  • Support statistical analyses, clinical study report, IB, regulatory related documents, publications and scientific presentations, and perform QC activities accordingly
  • Support cross functional activities related to biometrics and clinical program development as needed

Qualifications

  • Bachelor or master in computer sciences and statistics
  • 15 years in pharmaceutical / biotechnology companies, including 3 years in managerial role and/or overseeing CRO performance
  • Expert in SAS/STAT and R, with extensive knowledge in CDISC including SDTM, ADaM, RG and controlled terminologies
  • Working knowledge of EDC and common Data Management applications and knowledge of lab/image data and other external data sources
  • Experienced in study work including study design, authoring/reviewing study related documentations including protocol, CRF, DTA, SAP, DDT and TFL specification
  • Experienced in building statistical programming department, data standard and SOPs
  • Familiar with ICH guideline, GCP regulations, FDA / EMA / other regulatory authority guidance
  • Experienced in vendor selection and management and in managing multiple projects and being able to prioritize
  • Excellent communication and interpersonal skills, with the ability to translate statistical/analysis concept into operational strategies
  • Experience in statistical methods analyzing longitudinal data is preferred
  • Experience of working in start up companies, rare diseases, participation in regulatory interaction, leading regulatory submissions and participation in audit is preferred

Company

avidity banner

Our vision is to profoundly improve people’s lives by revolutionizing the delivery of RNA therapeutics. We’re utilizing our proprietary AOC platform to design, engineer, and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) with the precision of oligonucleotide-based therapies in order to redefine RNA therapeutics and more effectively target underlying genetic drivers of diseases. We are delivering on this vision by investing in our platform, our pipeline and our people.

Our commitment to rigorous and innovative science is matched only by our passion to see patients’ lives changed. We consistently challenge ourselves to Be AVID – Agile, Visionary, Integrated and Diverse.

We are assembling a diverse team experienced in rare disease and RNA therapies. Our team members bring expertise in research, development and commercial execution. We are focused on cultivating the right team to not only grow the company, but also to reflect the communities we serve. We are dedicated to employing and retaining a diverse and inclusive workforce at all levels of the organization to not only ensure that different backgrounds and perspectives are being heard and acted upon, but that our employees also feel understood, accepted and valued.

 

be avid

avidity team 3 avidty team 2

avidity team

Company info
Website
Phone
858-401-7900
Location
10578 Science Center Drive
Suite 125
San Diego
California
92121
US

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