Senior Biostatistics Lead, Clinical Trials

MSD; Rahway (NJ); Hybrid; USD 191,000 - 300,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ invites a statistical lead to join BARDS within R&D.

You will provide biostatistical leadership for Late Development Statistics, lead cross‑functional teams, design and analyze clinical trials, and interact with regulatory agencies to ensure studies meet worldwide requirements. The role requires a PhD or equivalent with substantial experience, expertise in SAS/R, and strong communication and leadership skills to mentor junior staff and drive innovative methods in

Qualifications

• Solid knowledge of statistical analysis methodologies and experimental design.
• Strong project management skills.
• Solid knowledge of statistical and data processing software e.g. SAS and/or R.
• Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
• Strong oral and written communication skills. Able to function effectively in a team environment.
• Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Responsibilities

• Serves as statistical lead in cross-functional project teams.
• Provides biostatistical leadership and support for Late Development Statistics projects.
• Interacts with Clinical, Regulatory, Statistical Programming, Data Management and Research Laboratories scientists for design and analysis of trials.
• May interact with ARO, CRO and external statistical consultants.
• Independently identifies technical problems in design, conduct and analysis of trials and proposes solutions.
• Develops protocols and data analysis plans, determining appropriate methodology.
• Participates in database design meetings to ensure high-quality data.
• Leads a team of statisticians and programming staff to meet requirements and regulatory needs.
• Evaluates software suitability and possible custom statistical development.
• Analyses trial data and interprets results to meet study objectives.
• Prepares reports for team, management, regulatory agencies, and investigators.
• Responds to queries on study design, analysis, and interpretation.
• Represents biostatistics in regulatory interactions including advisory committee presentations.
• Ensures accuracy of Statistical Review Aids submitted to agencies.
• Participates with management in discussions with regulatory personnel and investigators.
• Involved in research for innovative statistical methods in trial development.
• Mentors and guides junior staff in functional activities.

Skills

Statistical analysis

SAS

R

Clinical trials

Study design

Regulatory knowledge

Communication

Leadership

Education

PhD or equivalent in statistics/biostatistics

Tools

SAS

R

Job description

Merck & Co., Inc. in Rahway, NJ invites a statistical lead to join BARDS within R&D.

You will provide biostatistical leadership for Late Development Statistics, lead cross‑functional teams, design and analyze clinical trials, and interact with regulatory agencies to ensure studies meet worldwide requirements. The role requires a PhD or equivalent with substantial experience, expertise in SAS/R, and strong communication and leadership skills to mentor junior staff and drive innovative methods in