Pharmaron

Director, Biostatistics

Pharmaron  •  $170k - $185k/yr  •  Somerset, NJ (Onsite)  •  21 hours ago
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Job Description

Position: Director, Biostatistics

Salary Range: $165K-$180K

Location: Remote

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers To learn more, visit www.pharmaron.com

What You'll Do

Pharmaron is seeking an experienced Director of Biostatistics to provide scientific and operational leadership for our growing Biometrics organization. This is a highly visible role responsible for providing strategic statistical expertise across Phase I-IV clinical trials. The successful candidate will partner with cross-functional teams and clients to ensure the delivery of high-quality statistical solutions that support successful clinical development programs.

Key Responsibilities

  • Develop, review and improve SOPs, working instructions, standard templates and procedures to ensure all activities in accordance with internal and external quality standards, SOPs/WIs, ICH-GCP and/or any other applicable local and international regulations, guidelines and industry standards and improve productivity and efficiency of the team.
  • Maintain a positive, collaborative, results orientated work environment, build partnerships and teamwork, communicate to team in an open, transparent and objective manner.
  • Participate in and responsible for the internal and external audits, take the appropriate actions to the audit findings timely.
  • Provides support to Business Administration and Business Development, review project proposal and contract.
  • Establishes and maintains relationships with clients and vendors.
  • Provide statistical inputs/consultants on trial design, protocol and CRF development, perform sample size calculation, interact with clients with regard to statistical issues.
  • Authoring and review of statistical analysis plans, statistical reports and statistical methodology sections in clinical protocols and reports in different therapeutic areas from phase I to phase IV.
  • Attend the regular department operational and management meetings, meets regularly with VP to discuss staffing for upcoming studies and department development strategies.

What We're Looking For

  • Master's degree or higher in Biostatistics, Statistics, Mathematics, or a related scientific discipline (Bachelor's degree with equivalent experience will also be considered).
  • 8+ years of clinical biostatistics experience supporting clinical trials.
  • Experience authoring Statistical Analysis Plans and providing statistical input for clinical trial design.
  • Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial methodology.
  • Excellent communication and client-facing skills with the ability to collaborate across scientific, operational, and commercial teams.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

  • Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
  • 401(k) Retirement Plan with generous employer matching
  • Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
  • Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
  • 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
  • Employee Assistance Program (EAP), mental health resources, and wellness programs
  • Family-friendly benefits, including fertility support and maternity resources
  • Professional development and career growth opportunities within a leading global CRO/CDMO

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

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Pharmaron

About Pharmaron

Pharmaron: Global Life Sciences Services Provider

Stock Code: 300759.SZ/3759.HK

Founded in 2004, Pharmaron is a premier life sciences service provider that offers a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products.

Pharmaron’s Comprehensive CRO & CDMO Services

• Synthetic, Medicinal, and Analytical Chemistry Services

• Biology Services (e.g., in vitro screening, structural biology, biomarkers)

• DMPK Services (e.g., in vitro ADME, in vivo PK, PKPD, mass balance)

• Pharmacology Services (e.g., in vivo pharmacology, animal disease models, immunotoxicity)

• Drug Safety Assessment Services (e.g., toxicology, safety pharmacology, genetic toxicology)

• Radiochemistry and Isotopically Labelled Metabolism Services (e.g., 14C/Carbon-14 radiosynthesis, 3H/tritium radiosynthesis, QWBA, mARG)

• CMC Services (e.g., API manufacturing, process chemistry, formulation development)

• Clinical Development Services (e.g., First-in-Human [FIH], ethnobridging, microdosing Phase 0, absolute bioavailability)

Commitment to Excellence and Innovation

With a proven track record of success, Pharmaron continually invests in its people, facilities, and technologies to meet evolving scientific and regulatory demands. The company prides itself on enabling scientific breakthroughs and supporting its partners in advancing human health.

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Learn More: Explore Pharmaron’s services to discover how to accelerate your R&D programs. www.pharmaron.com.

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Keywords: CRO, CDMO, synthetic chemistry, medicinal chemistry, biology, radiochemistry, toxicology, First-in-Human, API manufacturing, PKPD, 14C radiosynthesis, discovery biologics, clinical development, small molecules, biologics, cell and gene therapy (CGT) products

Industry
Chemicals & Materials
Company Size
1,001-5,000 employees
Headquarters
Beijing, CN
Year Founded
2004
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