Study Lead Statistician - Product Facing

Company: Innova
Location: Thousand Oaks
Posted on: April 25, 2025

Job Description:

Innova Solutions has a client that is hiring for a Study Lead Statistician - Product Facing

Check below to see if you have what is needed for this opportunity, and if so, make an application asap.


Position type: Fulltime - Contract
Duration: 12 Months
Location: Thousand Oaks, CA (Remote)


As a Study Lead Statistician - Product Facing, you will:


Job Description:
Core Responsibilities:
- Provide statistical guidance, review, and contribution to protocols, SAPs; TFL shells; DMC Charters; SDF specifications (SDTM and ADaM); randomization specifications; other key-study related documentation, protocol deviations, data quality review
- Attend meetings for and provide statistical input into cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review
- Provide statistical guidance, review, and be responsible for statistical analysis of individual studies/projects
- Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as the statistical analyses of these endpoints (programmatically)
- Perform data-driven modeling during clinical studies
- Coordinate the creation of required outputs for Dose Level Review Meetings (DLRMs) as well as coordinate and participate in the DLRM
- Review TFLs created by statistical programming for consistency and accuracy
- Author analysis reports such as Flash Memo, and results section of the CSRs
- Manage timelines for all statistics-related deliverables by working with the cross-functional team members (e.g., programmers, study statisticians, clinical data managers, medical writers)
- Be familiar with all Company's policies, SOPs and other controlled documents related to study activities noted above
- Assist with study and systems audits conducted by Company GCA and external bodies

Minimum Education Required:
Master's degree in Statistics/Biostatistics or other subject with high statistical content with at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research (or PhD degree with at least 3 years' experience)
Strong understanding of statistical concepts related to the design and conduct of clinical studies
Strong ability to apply statistical methodologies in the analysis of clinical trials
Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
Previous experience in the development, author, and execution of protocols and SAPs, as well as review of CSRs
Strong SAS and/or R programming skills in conducting simulations and applying statistical concepts and methods based on complex study designs

Preferred Qualifications:
Master's degree in Statistics/Biostatistics or other subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Biostatistics or other subject with high statistical content and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
Leadership of at least 3 clinical studies/projects end-to-end with minimal oversight
Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
Experience in adaptive clinical trials and innovative study designs
Experience in the utilization of Bayesian statistics in clinical trials
Proficient R programming skills conducting simulations and applying statistical concepts and methods based on complex study designs

Thank you!
Harish Yadav
Phone: 213-797-4030
harish.yadav@innovasolutions.com

PAY RANGE AND BENEFITS:
Pay Range*: $95.00-$100.00 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.

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).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:
Named One of America's Best Employers for New Grads by Forbes (2024
Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)
One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)
One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
AWS Advanced Tier Services Partner with 100+ certifications


Website: https://www.innovasolutions.com/

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. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. - 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Keywords: Innova, Thousand Oaks , Study Lead Statistician - Product Facing, Other , Thousand Oaks, California