Senior Biostatistician

Senior Biostatistician

Posted Today by 1758196039

Negotiable
Outside
Remote
USA

Summary: The Senior Biostatistician will leverage statistical expertise to design and analyze clinical trials, collaborating closely with program partners to meet statistical deliverables and contribute to health authority submissions. Reporting to a franchise team leader, this role requires adherence to company guidelines and regulatory requirements while managing multiple clinical trials. The ideal candidate will possess a strong background in biostatistics and drug development, with proficiency in statistical software. This position is remote and classified as outside IR35.

Key Responsibilities:

  • Contribute with your statistical expertise to the design and analysis of one or more clinical trials or the clinical development plan of one compound/program.
  • Will closely collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials and contribute to HA submissions.
  • Will report to a franchise team leader, within the Biostatistics and Statistical Modelling organisation.
  • Will carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements.

Key Skills:

  • You have a master or doctorate (Ph.D.) degree in Statistics or related field with a minimum of 5+ years of experience (which may include doctoral research in field of biostatistics) (Master is a required qualification).
  • You have expertise in drug development, with a demonstrated track record of advanced knowledge of biostatistics and strong command of its application to clinical trials.
  • Demonstrates ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials.
  • You are proficient in statistical software (SAS and/or R).
  • You are able to collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials.
  • You can clearly explain complex statistical concepts in written and spoken English.
  • You are a team-player with focused attitude.
  • You are able to work autonomously as part of a cross-disciplinary team in a dynamic surrounding of a fast-growing biotech company with challenging timelines.

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other

Role:

  • Contribute with your statistical expertise to the design and analysis of one or more clinical trials or the clinical development plan of one compound/program.
  • Will closely collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials and contribute to HA submissions
  • Will report to a franchise team leader, within the Biostatistics and Statistical Modelling organisation
  • Will carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements

Education and Experience:

  • You have a master or doctorate (Ph.D.) degree in Statistics or related field with a minimum of 5+ years of experience (which may include doctoral research in field of biostatistics) (Master is a required qualification)
  • You have expertise in drug development, with a demonstrated track record of advanced knowledge of biostatistics and strong command of its application to clinical trials
  • Demonstrates ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials
  • You are proficient in statistical software (SAS and/or R);
  • You are able to collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials
  • You can clearly explain complex statistical concepts in written and spoken English
  • You are a team-player with focused attitude
  • You are able to work autonomously as part of a cross-disciplinary team in a dynamic surrounding of a fast-growing biotech company with challenging timelines

Knowledge, Skills and Abilities:

  • eCRT and Define knowledge
  • Proactive in nature
  • Project Lead abilities experience of working with cross functional teams and managing
  • TA experience is preferable (Immunology)
  • Exposure to regulatory related work
  • Exposure to latest Stat models and design approaches will be preferred
  • Proactive communication