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

Position type: Full-time - Contract

Duration: 12 Months

Location: Remote

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

Description

The Study Lead Statistician (SLS) for product facing work is responsible for leading statistical activities of clinical studies.

The SLS works closely with cross-functional team members to ensure their clinical studies are appropriately planned, have the required statistical power for success, comply with regulatory requirements and Client standards, and maintain statistical, as well as operational, integrity throughout the life of the study.

The SLS works closely with the Global Statistical Lead to ensure their study aligns with the overall product strategy. The SLS also works closely with the Study Statistician, who performs all the operational activities related to the statistics-related deliverables. The SLS is responsible for the integrity and quality of their study. The SLS also supports product level activities that could include regulatory activities as well as publication work.

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, and other communications.
Attend and be a contributor at Clinical Study Team Meetings. 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.
Initiate cross-functional team meetings as necessary (e.g., SAP review, TFL shell review, TFL 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. Collaborate with the study programming team for study deliverables. 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 Client policies, SOPs and other controlled documents related to study activities noted above. Assist with study and systems audits conducted by Client and external bodies.

Day to Day Responsibilities:

Working closely with 1) cross-functional team members to ensure their clinical studies are appropriately planned, have the required statistical power for success, comply with regulatory requirements and Client standards, and maintain statistical, as well as operational, integrity throughout the life of the study; 2) the Global Statistical Lead to ensure their study aligns with the overall product strategy; 3) the Study Statistician, who performs all the operational activities related to the statistics-related deliverables. Responsible for the integrity and quality of their study as well as supporting product level activities that could include regulatory activities as well as publication work.

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 skill in communicating statistical information clearly and concisely (written and oral). 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. Excellent oral and written English communication skills.
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 PhD degree with 5 years' experience).
Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal audiences (study/product team) and at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings.
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). Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, working with clinical development colleagues in study management, programming and IS.
Demonstrated ability to influence decision making. 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.

Basic Qualifications

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)

Top 3 Must Have Skill Sets:

At least 3-4 years' experience as lead statistician on clinical trials a sponsor company (SRO work is similar and good but need some exposure sponsor company background) 2. Must have a few years of experience with a sponsor
Strong SAS and/or R programming skills
Excellent written and oral communication skills
Must be independent worker. Be able to get a task and follow through relying on their experience

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.

Thank you!

Pradip Joshi

Email -

Phone: 213-401-2633

PAY RANGE AND BENEFITS:

Pay Range*: $100 - $105/Hr

*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 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.

American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.