Senior Manager/ AD of Biostatistics

Kelly Scientific Resources is a specialty service of Kelly Services®. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines.  Our scientists contribute to the research and development of therapeutics that change the lives of those affected with disease. We have an exciting direct hire opportunity in So. San Francisco for a Sr Manager/Associate Director Biostatistics to join a leading biotherapeutics client.  

 

Senior Manager/ AD of Biostatistics 

Objective of Position

We have an exciting opportunity for a Senior Manager or Associate Director of Biostatistics, depending on qualifications and experience, based in South San Francisco, CA. This position is to serve as a lead statistician for oncology and hematology studies, and to coordinate activities with other functional groups to ensure timeliness and quality of study deliverables for biostatistics.   

Essential Duties/ Responsibilities

  • Provide statistical expertise for design, analysis and reporting of clinical or scientific research studies
  • Collaborate with Clinical Sciences, regulatory affairs and other functions on protocol development, including choosing an appropriate study design and statistical methodology, defining endpoints, calculating sample size, and writing statistical sections of the protocol.
  • Develop statistical analysis plans and analysis specifications.
  • Collaborate with statistical programming to ensure that appropriate programs and

documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

  • Collaborate with data management and clinical operations over the course of trials to provide statistical input to study conducts and database development as well as data collection/cleaning.
  •  Collaborate with clinical pharmacology and translational medicine group to provide statistical input and support as needed Collaborate in publications, assist in data interpretation, and ensure consistency and accuracy in data presentation
  • Interact with medical writing and other functions on regulatory documents containing

statistical information and clinical data (e.g. Clinical Study Reports, Summary

documents for NDA submissions)

  • Contribute to the development of functional-level standards, SOPs, and templates.
  • Represent biostatistics on study/project teams.
  • Establish and maintain effective working relationships with study/project teams.

 

Requirements

  • Oncology drug development experience is preferred, though not required.
  • Experience with early development studies is desirable.
  • Competent in design, descriptive and inferential statistics in clinical trials, biopharmaceutical applications.
  • Ability to work within a team and work independently are required.
  • Excellent verbal and written communication skills are required.
  • Good interpersonal and project management skills are essential.
  • Knowledge of SAS and/or R is strongly desirable.

 

Education/Training

Ph.D. or M.S. in statistics, biostatistics, or related field with minimum 5 (Ph.D.) – 10 (M.S.) years of experience as biostatistician in the biotech/pharmaceutical industry or medical research. 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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