Senior Manager Biostatistics

Innova Solutions Inc; Austin (TX); Remote; USD 103,000 - 110,000; Full time

Benefits offered by this job

Medical & pharmacy coverage

Dental & vision insurance

401(k)

HSA & FSA

Life Insurance

Pet Insurance

Disability coverage

Legal protection

Paid time off & leaves

Employee Assistance Program

Job summary

Innova Solutions is seeking a Senior Manager Biostatistics to lead statistical activities for clinical trials on a remote, full-time contract basis. The role focuses on study design, sample size determinations, and regulatory interactions, with responsibilities spanning protocol and SAP authoring, DMC charter work, and cross-functional collaboration.

The ideal candidate holds a PhD in Statistics or Biostatistics with at least 5 years in pharma, and is proficient in SAS/R with CDISC experience.

Qualifications

• PhD or equivalent with post-graduate experience in the clinical trials setting.
• Experience with NDA/BLA/MAA activities and regulatory interaction.
• Experience as study lead statistician and contributing to cross-functional strategy discussions.
• Experience authoring SAP and TFL specifications.
• Familiarity with ICH guidelines and FDA/EMA guidance.
• Solid mathematical and statistical foundations.
• Proficient in SAS and R; CDISC knowledge is a plus.

Responsibilities

• Contribute to study level tasks from statistics perspective, including design and sample size.
• Author/review statistics sections in protocols, SAPs, and DMC charters.
• Create/review study randomization files.
• Develop TFL shell and review CRFs and other study documents.
• Participate in study-related meetings and ensure deliverables' statistical integrity.
• Provide statistically sound input to meet project objectives and regulatory requirements.
• Independently conduct analyses as suggested by data.
• Propose novel statistical approaches to improve efficiency and sensitivity.
• Contribute to developing standards and research in advanced statistical methodologies.
• Author/review regulatory documents or scientific publications.

Skills

Study design

Sample size planning

Regulatory collaboration

Statistical analysis

SAS

R

CDISC SDTM/ADaM

Education

PhD in Statistics or Biostatistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Innova Solutions has a client that is immediately hiring for Senior Manager Biostatistics.

Position type: Full Time Contract Duration: 3 months Contract Location: Remote.

As a Senior Manager Biostatistics, you will:

Job Details

Technical Skills:

Responsibilities

• Contribute to study level tasks from statistics perspective, including: study design and sample size determination
• Author/review statistics section in the protocol, SAP and DMC charter
• Create/review study randomization files
• Develop TFL shell and specification Review CRFs and other study documentations
• Active participation in study related meetings
• Ensure statistical integrity of deliverables
• provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
• 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
• Author/review regulatory documents or scientific publications

Requirements

• PhD in Statistics or Biostatistics with a minimum of 5 years (min 8 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 key contributor from statistics perspective and direct involvement in regulatory interaction
• Experienced as study lead statistician and contributing to strategy discussion in cross functional settings
• 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 and Benefits

Pay Range*: $75- - $80 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.

• 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

Equal Opportunity Employer

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 [email protected] or [phone]. 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.