Director Biostatistics at Advanced Group in Mountain View, California

Job Description:

Overview

Advanced Clinical is currently recruiting on the behalf of a mid-size pharmaceutical company based in South San Francisco, CA. We are seeking an experienced Director, Biostatistics candidate. This is a clinical-stage company with a broad portfolio of therapeutics in areas such as orphan and rare diseases. The organization offers a great salary, bonus, benefits, stability, and opportunities for career progression. Currently, the entire company works from home (WFH), but when it opens again, you'll typically be allowed 2-3 days WFH and flex on time/schedule.

Day-to-day responsibilities include:

Lead development and optimization of biometric processes with a specific focus on efficiency and quality

Manage external and internal biostatistics and statistical programming resources supporting studies and programs

Lead the study unblinding and validate TLFs post database lock

Create and review programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications

Coordinate and lead team review and consolidation of comments for SAP and mock-TLFs


Essential skills and requirements include:

Minimum of 10 years of clinical development/analysis and reporting experience within the biotech/pharmaceutical industry required

Minimum of 3 years of management/leadership experience required

Demonstrated experience and competencies in interaction with health authorities (FDA, EMA, and PMDA) and eCTD (NDA/BLA) submissions

Excellent knowledge of CDISC submission requirements regarding SDTM, ADaM, Define.xml, Reviewers Guide, Validation Rules, and Study Data Standardization Plan

Excellent programming skills of SAS or R

Education

Minimum of Ph.D. in Statistics/Biostatistics required

To be a best-fit your strengths must include:

• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.


• Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.


• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.


• Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.


• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.


• Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.


It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.


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