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 As Senior Manager Biostatistics, you will: 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
Responsibilities:- 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
Requirements:- 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.
Benefits:
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 & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.
