What are the responsibilities and job description for the Associate Director/Director of Biostatistics position at Penfield Search Partners?
Contact: Neisha Camacho/Terra Parsons - No 3rd party candidatesContract-to-HireOn-Site - Candidates must be local to Gaithersburg, MDJob Summary:Reporting to the Vice President of Biostatistics and Data Management, this individual will provide statistical leadership and serve as a study statistician within development. S/he will work collaboratively with clinical and development teams, including clinicians, clinical scientists, statistical programmers, data managers, regulatory, and clinical operations professionals, to plan, conduct, and analyze clinical studies of all phases. Responsible for the overall quality of statistical design, programming, analysis, and data reporting. Represents the company in interactions with outside statistical and data management service providers and participates in discussions with regulatory agencies.Essential Functions:Provides statistical expertise and leadership to ensure program objectives are in alignment with regulatory and clinical study designsWorking closely with statistical programmers to provide outputs and analyses to support NDA/BLA submission to regulatory authoritiesContribute to strategic planning and go/no go decision guidanceDirects development of statistical analysis plans and reviews statistical programmingEnsures timely and accurate delivery of clinical study data analysis resultsInterprets clinical trial data and contributes to the preparation of clinical manuscripts and regulatory submission documentsLead statistical strategy for clinical development programs, including MASH and obesity indications.Develop and review statistical sections of protocols, SAPs, CRFs, and clinical study reports.Collaborate with cross-functional teams (Clinical, Regulatory, Data Management, Medical Affairs) to ensure alignment on study design and analysis.Oversee statistical deliverables from CROs and ensure quality and compliance with ICH-GCP and regulatory standards.Perform or supervise statistical analyses for interim and final study results.Contribute to regulatory submissions (INDs, NDAs, BLAs) and responses to health authorities.Support external publications and presentations of clinical data.Mentor statistical programmer in AI/ML area and contribute to departmental growth and innovation.Evaluate and implement innovative statistical techniques that will provide benefit to clinical development programsJob Requirements (Essential knowledge, skills, and attributes):PhD or Master’s in Statistics, Biostatistics, or related field. MS with significant industry experienceAt least 5 years of prior experience working for biotech, pharma, or CRO5 years (Associate Director) / 8 years (Director) of experience in clinical trial statistics within biotech/pharma.Strong knowledge of statistical methods for clinical trials, including longitudinal data, survival analysis, and Bayesian approaches.Experience with regulatory interactions and submissions.Experience with metabolic diseases is highly desirableProficiency in SAS and/or R; experience with CDISC standards (SDTM, ADaM).Excellent communication and leadership skillsA self-directed individual who can excel both independently and as a team player in a fast-paced, entrepreneurial environmentHistory of successful participation within an interdisciplinary team.Preferred ExperiencePrior work in liver disease or metabolic indications (e.g., NASH/MASH, obesity)Experience with external control arms or synthetic cohort matchingFamiliarity with non-invasive biomarkers and imaging endpointsWorking experience or knowledge with AI/ML.
