Biostatistician – Developmental Analytics

Employer
PACT Pharma
Location
South San Francisco, California
Salary
Salary + Benefits + Pre IPO Equity
Posted
Apr 23, 2021
Ref
2021013
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

Biostatistician – Developmental Analytics  
 

PACT Pharma is an exciting, well-funded clinical stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient’s individual tumor and engineering T cells to kill that specific tumor. In principle, this technology can be used to treat any cancer type.

If you desire a stimulating fast paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.  We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!

We are in the San Francisco Bay Area, the heart of the world’s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.
 

We are about eradicating cancer, come join our team!

We are currently recruiting for Biostatistician who will report to the Senior Developmental Analytics Scientist and continue advancing PACT’s cutting edge engineered cell therapy product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives. This position provides statistical support for all phases of manufacturing development. This position will be based in South San Francisco.

This role will involve close interaction with Scientists and Directors of the PACT’s Process Development team, MSAT, QC, and Bioinformatics. The candidate should enjoy operating in an exceptionally dynamic and cooperative environment.

Responsibilities:

  • Design, develop, and apply computational and statistical methods to model complex biological processes (cell therapy manufacturing process, etc.) and analyze our novel complex datasets, including flow cytometry data, metabolic analysis, single cell sequencing, clinical information, and more
  • Provide written and verbal recommendations on statistical and data management issues
  • Collaborate on study protocol development for statistical methodology selection, sample size justification, and protocol acceptance criteria
  • Generate analysis datasets, tables, figures, and listings to support the analysis of process development and clinical trial data using SAS or JMP
  • Author statistical analysis plans, including development of table and listing shells
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Provide training to non-statisticians
  • Provide support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
  • Review output across programs to ensure consistency
  • Prepare statistical sections of process development or clinical study reports

Qualifications:

  • MS with 4+ years of relevant experience or PhD with 2+ year of relevant experience in Statistics, Biostatistics, Mathematics, or equivalent
  • Knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
  • Proficiency in statistical analysis software, including SAS, JMP, R, S-Plus, etc.
  • Experience with computational biology, genomics, statistical and machine learning optimization techniques for large complex datasets
  • Ability to communicate clearly and concisely, both verbally and in the form of written reports
  • Effective in solving and communicating complex issues to relevant stakeholders
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
  • Passionate about data integrity, quality assurance, and documentation
  • Clear understanding of T cell biology and tumor immunology is a plus.

PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate based on race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.