Senior Manager Biostatistics

A client of Innova Solutions is immediately hiring for the Senior Manager Biostatistics.

Position type: Full-time – Contract

Duration: 3 Months

Location: REMOTE

Job Description : The Senior Manager, Biostatistics acts as 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.

• Lead in study level tasks, ensuring statistical integrity; contribute strategically to the supporting projects from statistics perspective.
• Contribute to study level tasks from statistics perspective, including study design and sample size determination, protocol statistics section, SAP and DMC charter;
  Review study randomization files;
  Develop TFL shell and specification;
  Review CRFs and other study documentations;
  Active participation in study related meetings.
• Works collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
• Independently conduct analyses suggested by the data;
  Propose new / novel statistical methodological approaches to improve the efficiency and sensitivity of study results.
• Contribute to developing standards and research in advanced statistical methodologies.
• Review regulatory documents or scientific publications.

• PhD in Statistics or Biostatistics with a minimum of 3 years (min 6 years for Master's degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry.
• Experienced in NDA / BLA / MAA activities as a contributor from statistics perspective and direct involvement in regulatory interaction is preferred.
• Experienced in study level work including authoring SAP and TFL specification.
• Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance.
• Solid understanding of mathematical and statistical principles.
• Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies.

Pay Range* : $65.00-$85.00 per hour. Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Innova Solutions offers benefits (based on eligibility) that include the following :
Medical & pharmacy coverage, Dental / vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal &  protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).