Biostatistician

Job Title: Biostatistician Job Description
This Biostatistician role is responsible for leading and executing biostatistical activities that support all phases of clinical development and post-marketing efforts in the pain management space. You will collaborate closely with biostatisticians, statistical programmers, cross-functional partners, and contract research organizations to deliver high-quality statistical analyses and outputs that inform clinical and regulatory decision-making. The position focuses on rigorous clinical trial design, implementation of CDISC standards, and generation of robust evidence to support opioid-sparing pain management strategies and innovative therapies.
Responsibilities
- Conduct biostatistical activities to support all phases of clinical development and post-marketing programs, with a focus on pain-related indications.
- Design, analyze, and report randomized controlled clinical trials, including Phase II and Phase III studies in acute and chronic pain.
- Develop, review, and validate statistical analysis plans, tables, listings, figures, and other statistical deliverables for clinical trials and post-marketing studies.
- Collaborate closely with other biostatisticians, statistical programmers, and cross-functional team members to ensure statistical integrity and operational feasibility of study designs.
- Partner with contract research organizations and other external vendors, providing statistical oversight to ensure adherence to protocols, data standards, and quality expectations.
- Apply clinical trial design principles, including adaptive trial designs, to optimize study efficiency and scientific rigor.
- Implement and oversee the use of CDISC standards, including SDTM and ADaM, to ensure consistent, high-quality data structures and facilitate regulatory submissions.
- Generate high-quality analytical outputs and interpret results to inform clinical development strategies, regulatory submissions, and post-marketing decisions.
- Communicate complex statistical concepts and results to non-statisticians in clear, non-technical language to support cross-functional understanding and decision-making.
- Balance scientific rigor with operational and business considerations in a fast-paced development environment, prioritizing tasks and managing multiple timelines.
- Contribute to the preparation of documents for regulatory interactions by providing statistical input and ensuring alignment with regulatory expectations.
- Support initiatives that leverage real-world evidence and observational research methodologies to inform product adoption and label expansion, as appropriate.
- Adhere to standard operating procedures, processes, and quality control practices associated with biostatistics in the pharmaceutical and biotech industry.
Essential Skills
- Strong understanding of clinical trial design principles, including adaptive trial designs.
- Proven ability to design, analyze, and report randomized controlled trials, particularly in clinical development settings.
- Strong proficiency in SAS programming, including hands-on experience with statistical analyses for clinical trials.
- Extensive hands-on experience with CDISC methodologies and industry data standards, including SDTM and ADaM.
- Ability to effectively communicate complex statistical analyses and concepts to non-statisticians in clear, non-technical language.
- Demonstrated ability to manage multiple priorities and timelines while consistently delivering high-quality outputs.
- Working knowledge of regulatory guidelines and expectations in pharmaceutical and biotech development.
- Understanding of standard operating procedures, processes, and quality control practices related to biostatistics in the pharmaceutical industry.
- Masters degree in statistics or biostatistics from an accredited college or university.
- Minimum of 4 years of experience within the biotech, pharmaceutical, or a closely related industry.
- Experience performing statistical responsibilities for the design, analysis, and reporting of randomized controlled clinical trials.
Additional Skills & Qualifications
- Experience supporting clinical development programs in acute or chronic pain indications.
- Experience with Phase II and Phase III clinical trials in pain studies.
- Experience in SAS programming beyond basic analysis, including advanced programming techniques and validation.
- Experience with R programming is a plus.
- Familiarity with real-world evidence and observational research methodologies, such as causal inference, is a plus.
- Experience supporting regulatory interactions, including preparation of statistical sections for submissions or responses, is a plus.
- Experience with adaptive trial design implementation and analysis.
- Experience with CRO oversight and cross-functional collaboration in a clinical development environment.
- Interest in or exposure to opioid-sparing pain management strategies, including postsurgical, chronic, and musculoskeletal pain.
- Interest in innovative modalities such as injectables, devices, and gene therapy within a clinical development context.
Work Environment
The work environment centers on innovative, non-opioid pain management with a focus on long-acting, locally administered therapies for postsurgical, chronic, and musculoskeletal pain. The organizations strategy emphasizes reducing opioid exposure while improving recovery outcomes through extended-duration anesthesia, injectables, devices, and gene therapy innovation. You will work in a collaborative, fast-paced research and development setting that relies heavily on SAS-based statistical programming, CDISC data standards, and cross-functional teamwork with clinical, regulatory, and external partners. The environment encourages strategic thinking around label expansion of proven assets, increased use of real-world evidence and investigator-initiated trials to support adoption, and building a pipeline that bridges injectables, devices, and gene therapy. Work hours and dress expectations are consistent with a professional office-based or hybrid clinical development setting, with an emphasis on collaboration, quality, and scientific rigor.
Job Type & Location
This is a Contract to Hire position based out of Parsippany-Troy Hills, NJ.
Pay and Benefits
The pay range for this position is $80.00 - $95.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Parsippany-Troy Hills,NJ.
Application Deadline
This position is anticipated to close on Oct 12, 2026. About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
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