Lead Biostatistician

Overview:

We are seeking a Lead Biostatistician to support the to support the National Human Genome Research Institute (NHGRI)'s Clinical Research Support in Rockville, MD. NHGRI believe that advances in genomics research are transforming our understanding of human health and disease.

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.

Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

*This is a forecasted position, and it is contingent upon contract award.

Responsibilities:

• Lead the statistical design, analysis, interpretation, and reporting of clinical trials and related clinical research studies.
• Provide strategic statistical input into study protocols, statistical analysis plans (SAPs), case report forms, endpoint definitions, and data collection strategies.
• Develop, review, and approve statistical methodologies, including sample-size determinations, randomization approaches, interim analyses, multiplicity adjustments, and strategies, as applicable.
• Oversee programming and analysis activities to ensure accurate, reproducible, and timely delivery of tables, listings, figures, and statistical reports.
• Direct analyses of complex clinical data, including longitudinal, repeated-measures, time-to-event, subgroup, and sensitivity analyses.
• Partner with clinical, data management, statistical programming, regulatory, medical writing, and operational teams to ensure statistical considerations are integrated throughout study planning and execution.
• Interpret results and communicate statistical findings clearly to technical and non-technical stakeholders.
• Lead or contribute to clinical study reports, manuscripts, abstracts, presentations, and responses to reviewer, sponsor, or regulatory questions.
• Ensure that statistical methods and deliverables adhere to applicable quality standards, study requirements, and relevant regulatory expectations.
• Mentor and provide technical oversight to biostatisticians and statistical programmers.
• Identify opportunities to improve statistical processes, analytical standards, quality controls, and team capabilities.
• Additional duties as assigned.

Qualifications:

• PhD in statistics, biostatistics, or a closely related field.
• Extensive experience serving as the lead statistician for multiple clinical trials, including late-phase, pivotal, or complex studies.
• Experience supporting regulatory submissions, sponsor interactions, and/or responses to health authority questions.
• Experience supervising, mentoring, or providing technical review for statisticians and programmers.
• A strong record of peer-reviewed scientific publications or conference presentations.
• Expertise in therapeutic-area-specific clinical research, real-world evidence, adaptive design, Bayesian methods, or advanced causal inference methods.

Physical Requirements:

The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.

Physical Demands

• Constantly conduct sedentary work that primarily involves sitting/standing.
• Occasionally conduct light work that includes moving objects up to 20 pounds.
• Constantly push or pull less than 25 pounds.
• Rarely push or pull 25 -45 pounds.
• Rarely reach above shoulder level.
• Constantly use both hands.
• Rarely stand or walk for more than 25 minutes.
• Rarely bend, reach, or twist repeatedly.
• Constantly have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.

Physical Activities

• Occasionally move about to accomplish tasks or move from one worksite to another.
• Constantly communicate with others to exchange information.
• Constantly assess the accuracy, neatness, and thoroughness of the work assigned.

Environmental Conditions

• Constantly work where no adverse environmental conditions are expected.

Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.