Senior Director, Biostatistics (MGM)
Job Location: NJ
Date Posted: 2021-02-12
NJ (partially remote)
Leader in developing treatments for patients experiencing Rare Pulmonary Disease is looking for a Senior Director of Biostatistics to join their growing team. Reporting to the Head of Biometrics this position will act as the statistical leader and expert for a group of indications to ensure the quality and consistency of statistical contributions.
Identify, justify, and optimize statistical strategies for responsible clinical development programs, regulatory submissions, and regulatory interactions. Ensure strategic alignment and consistency in statistical contributions within the responsible area. Take initiatives and provide leadership to resolve complex statistical issues within the responsible area Collaborate with Clinical Sciences to optimize the study design and contribute to drug development plans. Effectively communicate on complex statistical topics in a professional manner to statistical and nonstatistical audiences; tailor message to audience to ensure critical information is communicated in an actionable manner. Contribute to documents submitted to Health Authorities globally. Represent Biostatistics at meetings with regulatory authorities.
MS or PhD in Statistics or Biostatistics required. Minimum of 12 years of clinical trial experience (PhD) or minimum of 15 years of clinical trial experience (MS) in a biotech, pharmaceutical, or CRO setting. Experience in regulatory submissions and regulatory interactions. Strong knowledge of statistical methodologies applicable to Clinical Research. Strong knowledge of clinical research and medical terminology for study design and results interpretation. Knowledge of statistical ethics, guidelines, and principals established by US Food and Drug Administration (FDA), European Medicines Agency (EMA), International Conference on Harmonisation (ICH), and the American Statistical Association. Excellent communication skills (verbal and written). Excellent presentation skills to convey complex topics to leadership teams of various levels.
Please contact Manja Molan at email@example.com
Recruiter LinkedIn Page