Senior Principal Biostatistician

JOB RESPONSIBILITIES

Project level

• May act as program statistician for biosimilar development programs within cross-functional global development teams and represents Biostatistics as part of development plan.
• Provide scientific, strategic and statistical input to clinical development strategies and trial designs for biosimilar development programs (including Biomarker, PK, PK/PD and efficacy/safety studies)
• Champion, drive and implement innovative efficient trial designs and novel statistical methods within programs
• Lead planning and execution of innovative statistical analyses and eCTD preparation for regulatory submission and post-marketing activities including publications
• Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables.
• Significantly contributes to project team preparation for Advisory Committees and meetings.

Study level

• Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities.
• Be responsible for sponsor oversight of trial-related activities performed by CROs/external partners
• Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required.
• Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate.
• Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.

Other

• Establish and maintain collaborative working relationships and effective communication within Biostatistics department, BCD, Global Program Teams,
• Explain statistical concepts in an easily understandable way to non-statisticians and provide relevant statistical interpretation and justification of analysis results

EDUCATION AND SKILLS REQUIRMENT

Education

PhD, PharmD or MS with honors in biometrics, statistics, mathematics, pharmacometrics, clinical pharmacology, or other quantitative discipline preferred
PhD with 3+ years’ experience preferred OR MS with 7+ years’ experience

Good knowledge and evidence of hands-on experience in at least 3 of the following key areas in pharmaceutical industry, vendors and/or academia:

• •  Design of clinical development programs (including Biomarker, PK, PK/PD and efficacy/safety studies)
  • Clinical efficacy equivalence trials
  • Adaptive designs and clinical trial simulation
  • Application of clinical pharmacology and/or pharmacometrics methods
  • Bayesian trial design and analysis
  • Advanced statistical modelling (e.g. evaluation of separate treatment effects in combination treatment regimens)
  • Application of Real World Evidence and machine learning in clinical trials

Skills

Proficiency in use of statistical software packages (e.g. SAS, R)
Clinical, pharmacological and therapeutic knowledge
Good interpersonal and communication skills (verbal and writing) to bridge scientific and business needs, integrating quantitative sciences

Tagged as: R, SAS