Principal Biostatistician

Location
Bannockburn, IL, US
Posted
Jan 12, 2021
Ref
5828
Hotbed
BioMidwest
Required Education
Doctorate/PHD/MD
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Principal Biostatistician, supports statistical needs and provide statistical expertise to help guide strategy, design and execution of clinical development programs for a dynamic, fast-paced clinical stage biotechnology company.

Responsibilities
  • Key contributor to study design and analysis of clinical data related to company's development programs and support of regulatory and publications functions.
  • Ensure departmental goals and deliverables are met. Plan, analyze, and summarize thevresults of individual clinical studies or groups of studies (integrated summaries). Program, oversee programming of, and/or review statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Standard Operating Procedures (SOPs) or study specific guidelines.
  • Efficiently and effectively coordinate statistical activities for multiple projects simultaneously, including providing expertise and guidance to relevant aspects of protocol development.
  • Proactively contribute statistical expertise to synopses and protocols.
  • Develop statistical analysis plans (SAPs), end of study clinical study reports (CSR), and other relevant documents with biostatistics components. Ensure that the approved SAPs are correctly implemented by the CRO statisticians and their programming teams.
  • Interact with project team, as well as key internal and external stakeholders.
  • Maintain awareness of project tasks and effectively communicate the status of such tasks to the Head of Biostatistics and Head of Clinical Development.
  • Program in SAS and/or R to create output tables and/or listings as needed, including presentation-ready tables, listings, and figures.
  • Ensure that these outputs are documented according to company standards.
  • Provide guidance for external (CRO) statisticians and ensure that the CROs maintain the expected timelines.
  • Verify CRO statistical outputs and deliver outputs to the teams.
  • Review draft deliverables from CRO and collect and collate comments from review teams.
  • Perform other responsibilities as required by the Department and participate in process improvement initiatives.
  • Contribute to SOP development in the Biostatistics department and in all Clinical departments.
  • Other related job duties as assigned.

Qualifications
  • Master's degree in biostatistics or statistics with 8 years' relevant experience or doctoral degree in biostatistics or statistics with 6 years relevant experience.
  • Experience in statistical design, analysis, and reporting methodology for basic and complex studies along with experience in contributing to statistical activities in clinical research.
  • Excellent programming skills in SAS and R, including designing and developing output tables, listings, and figures.
  • Experience with clinical and operational elements of pharmaceutical development.
  • Understanding of the principles of ICH GCP and regulatory requirements is essential.
  • Candidates must have excellent analytical, verbal, and written presentation skills with a thorough working knowledge of SAS, R, and other relevant statistical software as well as working knowledge of Microsoft Office applications including Word, Excel, PowerPoint and Visio.
  • Excellent organizational and analytical skills, strong oral and written communication skills, and able to work in a high paced, timeline driven setting.
  • Highly effective interpersonal skills and the ability to continually demonstrate poise, tact, and diplomacy are necessary.
  • Ability to travel


The level of this position will be based on the final candidate's qualifications.

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and employee recognition scheme are some of the benefits you will receive as an employee of Novartis Gene Therapies.

Please note this job description is 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.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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