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Company

Ascendis Pharma · 3 days ago

Director, Biostatistics - Job ID: 1518

Palo Alto, CA

Full-time

Remote

Director/Executive

10+ years exp

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BiotechnologyClinical Trials

H1B Sponsor Likely

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Responsibilities

Represents biostatistics project lead, with accountability of biostatistics deliverables, including biostatistics support of clinical development planning, clinical study designs, protocol writing, analysis planning/execution, clinical study report table/figure/listings, statistical interpretations, and regulatory submissions

Provides leadership and perform study data reviews during clinical studies to ensure that clinical studies are in the right course as planned with proper checking of assumptions used for statistical analyses

Collaborates with cross functional peers to facilitate and optimize the product development and registration process to meet deliverables and timelines for statistical data analysis and reporting

Manages biostatistics vendors, identify potential risks and resolve issues with CROs

Manages study biostatistics(s) and/or consultant(s)

Assists non‐routine projects as applicable in support of drug development activities

Qualification

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StatisticsBiotechnology experiencePharmaceutical industry experienceSAS programmingStatistical analysisGCP knowledgeICH guidelines knowledgeFDA regulations knowledge

Required

PhD in statistics or equivalent, with at least 10 years of relevant experience in biotechnology or pharmaceutical industry

Excellent interpersonal and communication skills both written and verbal

Extensive knowledge of GCP, ICH guidelines, FDA regulations

Strong knowledge and skills of programming in SAS

Ability to examine issues from various perspectives and apply appropriate concepts to address situations

Demonstrated experience in providing statistical input and direction into the design of clinical studies, data analytic approaches, interpretation of findings and crafting of key messages

Benefits

401(k) plan with company match

Medical, dental, and vision plans

Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance

Company-provided short and long-term disability benefits

Unique offerings of Pet Insurance and Legal Insurance

Employee Assistance Program

Employee Discounts

Professional Development

Health Saving Account (HSA)

Flexible Spending Accounts

Various incentive compensation plans

Accident, Critical Illness, and Hospital Indemnity Insurance

Mental Health resources

Paid leave benefits for new parents

Company

Ascendis Pharma

Ascendis Pharma built a high-value pipeline that aims to change the clinical treatment paradigms.

Founded in 2006

Palo Alto, California, USA

501-1,000 employees

http://ascendispharma.com

H1B Sponsorship

Ascendis Pharma has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (5)

2022 (3)

2021 (3)

2020 (2)