1+ months

Senior Director Biostatistics

ACADIA Pharmaceuticals
Princeton, NJ 08540
  • Job Code
    117173794
ACADIA Pharmaceuticals

ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

Position Summary:

Oversees the design, development, and implementation of high performance, innovative biostatistics workflows and provides technical leadership and supervision of biostatisticians. Oversees trial planning and analysis activities in support of clinical trials, regulatory approval, and marketing efforts. Prepares development programs for new drug indications. Provides analysis planning for clinical studies, statistical input to clinical study reports, and statistical support to other disciplines related to clinical statistics. Responsible for the overall quality of all statistical design, analysis and reporting deliverables.

Primary Responsibilities:

  • Develops and implements the vision to support research & development, pre-clinical, and clinical data analysis.
  • Oversees advanced biometrical, statistical, and technical activities for the design, analysis and interpretation of statistical data.
  • Provides strategic thinking and statistical expertise to define the right questions to be answered in the design of clinical trials; specifically contributes from a statistical perspective to the creation of the Clinical Development Plans.
  • Directs the design, development, modification and evaluation of a technical infrastructure to expedite the operation and evaluation of clinical trials.
  • Manages the design, monitors the statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Manages the evaluation and design of clinical data statistics.
  • Provides primary statistical input for clinical design studies.
  • Directs development and support of high performance data analysis pipelines.
  • Directs statistical support for commercially available products.
  • Provides analytic support to aid in decision making in the development of new laboratory developed tests.
  • Responsible for leading biostatistics team members in ensuring effective, timely, high quality and compliant delivery of goals and accountabilities of multiple ongoing projects.
  • Ensures all department work is performed consistent with Good Clinical Practices (GCP), International Conference on Harmonization (ICH), 21 CFR part 11, internal SOPs and training, and international regulatory requirements.

Education/Experience/Skills:

Masters or Ph.D. degree in (bio) statistics or related field. An equivalent combination of relevant education and applicable job experience may be considered. Minimum of 12 years progressively responsible experience in clinical research with a focus on biostatistics and 8 years in a leadership role. Experience includes managing statisticians on clinical trials and/or clinical research projects that have delivered the agreed-upon end products on time, and prior guidance of lower level or less experienced staff. Pharmaceutical industry experience and detailed knowledge of regulatory aspects of statistical design and analysis are required. CNS experience (e.g. neurology, psychiatry) is strongly preferred.

Must possess:

  • Ability to code complex statistical analyses; proficient with good coding practices.
  • Demonstrated contribution to analysis of clinical trials and/or clinical research projects, participation in preparation of academic manuscripts or other written summaries of analysis results, and thorough experience with the drug development process.
  • Ability to consistently demonstrate leadership qualities in a variety of settings and through multiple experiences and ability to manage project responsibilities independently across a variety of different projects.
  • Excellent interpersonal communication and networking skills with the ability to build cross functional bridges.
  • Established track record (publications, research and presentations) in biostatistics with a robust network of statistical experts.
  • Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
  • Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.

Scope:

Establishes strategic plans for designated function(s) and may participate with others in management to align objectives across the organization. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area(s) and related organizational objectives. Erroneous decisions will have a serious impact on the overall success of functional, or company operations.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.


PI117173794

<b>ACADIA Pharmaceuticals</b><br/><br/>ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br/><br/><p><strong><u>Position Summary:</u></strong></p> <p>Oversees the design, development, and implementation of high performance, innovative biostatistics workflows and provides technical leadership and supervision of biostatisticians. Oversees trial planning and analysis activities in support of clinical trials, regulatory approval, and marketing efforts. Prepares development programs for new drug indications. Provides analysis planning for clinical studies, statistical input to clinical study reports, and statistical support to other disciplines related to clinical statistics. Responsible for the overall quality of all statistical design, analysis and reporting deliverables.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Develops and implements the vision to support research & development, pre-clinical, and clinical data analysis.</li> <li>Oversees advanced biometrical, statistical, and technical activities for the design, analysis and interpretation of statistical data.</li> <li>Provides strategic thinking and statistical expertise to define the right questions to be answered in the design of clinical trials; specifically contributes from a statistical perspective to the creation of the Clinical Development Plans.</li> <li>Directs the design, development, modification and evaluation of a technical infrastructure to expedite the operation and evaluation of clinical trials.</li> <li>Manages the design, monitors the statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Manages the evaluation and design of clinical data statistics. </li> <li>Provides primary statistical input for clinical design studies.</li> <li>Directs development and support of high performance data analysis pipelines.</li> <li>Directs statistical support for commercially available products.</li> <li>Provides analytic support to aid in decision making in the development of new laboratory developed tests.</li> <li>Responsible for leading biostatistics team members in ensuring effective, timely, high quality and compliant delivery of goals and accountabilities of multiple ongoing projects.</li> <li>Ensures all department work is performed consistent with Good Clinical Practices (GCP), International Conference on Harmonization (ICH), 21 CFR part 11, internal SOPs and training, and international regulatory requirements.</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <p>Masters or Ph.D. degree in (bio) statistics or related field. An equivalent combination of relevant education and applicable job experience may be considered. Minimum of 12 years progressively responsible experience in clinical research with a focus on biostatistics and 8 years in a leadership role. Experience includes managing statisticians on clinical trials and/or clinical research projects that have delivered the agreed-upon end products on time, and prior guidance of lower level or less experienced staff. Pharmaceutical industry experience and detailed knowledge of regulatory aspects of statistical design and analysis are required. CNS experience (e.g. neurology, psychiatry) is strongly preferred.</p> <p>Must possess:</p> <ul> <li>Ability to code complex statistical analyses; proficient with good coding practices.</li> <li>Demonstrated contribution to analysis of clinical trials and/or clinical research projects, participation in preparation of academic manuscripts or other written summaries of analysis results, and thorough experience with the drug development process.</li> <li>Ability to consistently demonstrate leadership qualities in a variety of settings and through multiple experiences and ability to manage project responsibilities independently across a variety of different projects.</li> <li>Excellent interpersonal communication and networking skills with the ability to build cross functional bridges.</li> <li>Established track record (publications, research and presentations) in biostatistics with a robust network of statistical experts.</li> <li>Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.</li> <li>Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.</li> </ul> <p><strong><u>Scope:</u></strong></p> <p>Establishes strategic plans for designated function(s) and may participate with others in management to align objectives across the organization. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area(s) and related organizational objectives. Erroneous decisions will have a serious impact on the overall success of functional, or company operations.</p> <p><strong><u>Physical Requirements:</u></strong></p> <p>While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. </p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/NaYnJYf6N42kCRBOuqoYe"> <p>PI117173794</p>

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Posted: 2020-01-16 Expires: 2020-02-16

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Senior Director Biostatistics

ACADIA Pharmaceuticals
Princeton, NJ 08540

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