Director/Associate Director, Biostatistics

6 days ago

boston, United States PepGen Full time

Director / Associate Director, Biostatistics

As Director / Associate Director of Biostatistics, you will work in collaboration with the Head of Biostatistics to provide strong statistical support to advance PepGen’s clinical development programs. You will serve as the statistical subject-matter expert on our cross-functional teams with significant contribution to protocol development, study design, statistical analysis, regulatory submissions, publications and presentations, as well as managing CRO and external vendors.


Responsibilities:

  • Lead the development of statistical sections of clinical study protocols, statistical analysis plans (SAP) and conduct the analysis and reporting of clinical trial data, including review of Tables, Listings, Figures (TLFs), SDTM and ADaM specifications, clinical study reports (CSR), and regulatory submission documents
  • Provide strategic input to optimize trial designs for pivotal registrational studies; maintain advanced competencies in statistical methodology and innovative trial designs, particularly in therapeutic areas such as neuromuscular diseases or other rare diseases, familiarity with ICH, FDA, and EMA guidelines
  • Representing the biostatistics function, proactively collaborate with internal and external cross functional teams to ensure timely statistics deliverables; oversee CRO statistical activities and effectively manage contractors and vendors
  • Contribute to the development of Biostatistics SOPs and standards
  • Effectively communicate complex statistical concepts in written and verbal context to a broad audience


Requirements

  • Minimum of MS required (Ph.D. strongly preferred) in Biostatistics, Statistics, or other related fields with 6+ years of overall experience in drug development in the pharmaceutical industry
  • Experience in therapeutic areas such as neuromuscular diseases or other rare diseases preferred
  • Knowledgeable about a broad range of statistical topics in different phases of drug development, including efficacy, safety, and PRO endpoints and innovative study designs
  • Regulatory (s)NDA/BLA/MAA submission experience strongly preferred
  • Must have hands-on experience with SAS and R programming in clinical trials
  • Experience with managing CROs and contractors
  • Ability to work onsite in Boston Office Tuesday – Thursday

Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.


About PepGen:

PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, visit www.pepgen.com or follow PepGen on Twitter and LinkedIn.

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