16 days old

Executive Director Biostatistics

ACADIA Pharmaceuticals
San Diego, CA 92101
  • Job Code
    117901921
ACADIA Pharmaceuticals

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

Position Summary:

Acadias Head of Biostatistics is a senior leadership position within the Biometrics organization and a key member of the Biometrics Leadership Team. The person in this position holds overall accountability for the statistical aspects (both strategic and technical) of all drug development projects. This individual will lead, manage and develop a Team of internal Statisticians, ensuring timely and accurate delivery of statistical designs, analyses, reports, and regulatory submissions. Independently, this individual will provide strategic statistical input to drug development, including feasibility assessments, development plans, complex study designs, interpretations, and follow up.

Primary Responsibilities:

  • Develops and implements the vision to support research & development, pre-clinical, and clinical data analysis.
  • Oversees advanced 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 bio 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 the biostatistics team in ensuring effective, timely, high quality and compliance management and delivery of goals and accountabilities of multiple ongoing projects.
  • Ensures all department work is performed consistent with Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), 21 CFR part 11, internal SOPs and training, and international regulatory requirements.

Education/Experience/Skills:

Minimum of a Masters degree in (bio) statistics or related field, An equivalent combination of relevant education and applicable job experience may be considered. Minimum of 15 years progressively responsible experience in clinical research with a focus on biostatistics and 10 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 required.

Must possess:

  • Demonstrated contribution to analysis of clinical trials and/or clinical research projects, and/or participation in preparation of academic manuscripts or other written summaries of analysis results, 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 statistician experts.
  • Established track record of successfully leading a Team of Statisticians.
  • 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.
  • Solid knowledge of SAS programming and at least some other significant statistics software (e.g., R, S-Plus, PASS) is required.
  • Ability to code complex statistical analyses; proficient with good coding practices.

Scope:

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

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. Employee must occasionally lift and/or move up to 15 pounds.


PI117901921

<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>Acadias Head of Biostatistics is a senior leadership position within the Biometrics organization and a key member of the Biometrics Leadership Team. The person in this position holds overall accountability for the statistical aspects (both strategic and technical) of all drug development projects. This individual will lead, manage and develop a Team of internal Statisticians, ensuring timely and accurate delivery of statistical designs, analyses, reports, and regulatory submissions. Independently, this individual will provide strategic statistical input to drug development, including feasibility assessments, development plans, complex study designs, interpretations, and follow up.</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 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 bio 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 the biostatistics team in ensuring effective, timely, high quality and compliance management and 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 Harmonisation (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>Minimum of a Masters degree in (bio) statistics or related field, An equivalent combination of relevant education and applicable job experience may be considered. Minimum of 15 years progressively responsible experience in clinical research with a focus on biostatistics and 10 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 required.</p> <p>Must possess:<em> </em></p> <ul> <li>Demonstrated contribution to analysis of clinical trials and/or clinical research projects, and/or participation in preparation of academic manuscripts or other written summaries of analysis results, 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 statistician experts.</li> <li>Established track record of successfully leading a Team of Statisticians.</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> <li>Solid knowledge of SAS programming and at least some other significant statistics software (e.g., R, S-Plus, PASS) is required.</li> <li>Ability to code complex statistical analyses; proficient with good coding practices.</li> </ul> <p><strong><u>Scope:</u></strong></p> <p>Establishes strategic plans for designated function(s) and participates with others in management to align objectives across the organization. Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long term success of the company. </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. Employee must occasionally lift and/or move up to 15 pounds. </p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/wy7GDYFnXqwWFJVoiqaOp"> <p>PI117901921</p>

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Posted: 2020-02-08 Expires: 2020-03-10

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Executive Director Biostatistics

ACADIA Pharmaceuticals
San Diego, CA 92101

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