Senior Manager, Biostatistics

The Steely Group; California; Hybrid; USD 100,000 - 140,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Senior Manager, Biostatistics. This role involves leading statistical study tasks, providing technical input, and collaborating with cross-functional teams to ensure the integrity and efficiency of clinical studies. The ideal candidate will have a PhD in Statistics or Biostatistics, with substantial experience in clinical trials and regulatory interactions. Proficiency in SAS and R is essential.

Qualifications

• Minimum 3 years experience in clinical trials for PhD holders.
• Experience in NDA/BLA/MAA activities preferred.

Responsibilities

• Lead statistical study tasks and ensure integrity.
• Collaborate with teams for statistical data analysis.

Skills

Statistical Integrity

Problem-Solving

Organization

Education

PhD in Statistics or Biostatistics

Master’s Degree

Tools

SAS

R

Job description

The Senior Manager, Biostatistics acts as a statistical study lead; provides technical input and biostatistical support on the design and conduct of clinical studies; participates in the evaluation, interpretation, and reporting of study results; performs statistical analyses; provides timely support to the project teams on all statistical matters.

Responsibilities :

1. Lead in study level tasks, ensuring statistical integrity; contribute strategically to the supporting projects from a statistical perspective.
2. Contribute to study level tasks from a statistical perspective, including study design and sample size determination, protocol statistics section, SAP, and DMC charter.
3. Review study randomization files.
4. Develop TFL shell and specifications.
5. Review CRFs and other study documentation.
6. Participate actively in study-related meetings.
7. Collaborate within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
8. Independently conduct analyses suggested by the data.
9. Propose new or novel statistical methodological approaches to improve the efficiency and sensitivity of study results.
10. Contribute to developing standards and research in advanced statistical methodologies.
11. Review regulatory documents or scientific publications.

Requirements / Qualifications

1. PhD in Statistics or Biostatistics with a minimum of 3 years (or 6 years for Master’s degree) of post-graduate experience in the clinical trials setting within the pharmaceutical industry.
2. Experience in NDA / BLA / MAA activities as a contributor from a statistical perspective and direct involvement in regulatory interactions is preferred.
3. Experience as or capability to act as a study lead statistician and contribute to strategy discussions in cross-functional settings.
4. Experience in study-level work including authoring SAP and TFL specifications.
5. Familiarity with ICH guidelines, FDA / EMA / other regulatory authority guidance.
6. Solid understanding of mathematical and statistical principles.
7. Detail-oriented with strong organization, problem-solving, and prioritization skills; demonstrated ability to manage multiple tasks according to company timelines.
8. Proficiency with SAS and R; preferably with knowledge of CDISC standards including SDTM, ADaM, and controlled terminologies.