Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teams.
Responsible for writing statistical methodology section of the protocol, including sample size calculation.
Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE.
Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities.
Direct the activities of internal and external statistical programmers to ensure the intended analyses are performed, and analysis data sets and their specifications are in place following CDISC standards.
Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents.
Participate in operations meetings and address issues related to biostatistics.
Support and participate in the preparation of study reports, regulatory submissions and annual IND safety update reports.
Perform ad hoc analyses and validation of analysis results.
Develop and contribute to Biometrics SOPs and standard working documents meeting regulatory requirements throughout biometrics processes, including IWRS/EDC, STDM, statistical programming for TLFs and data reporting.
Write simulation code and simulation report in compliance with regulatory agency requirements for adaptive design trials.
Ph.D. in statistics/biostatistics with minimum 6-10 years of biopharmaceutical statistics experience; Masters degree in statistics or biostatistics with a minimum of 8-12 years of experience with specific experience in late stage drug development, including phase IIb, phase III and submissions in the pharmaceutical industry.
Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
Experience in Biostatistics, SAS programming and clinical data management in a regulated clinical research environment.
Knowledge of adaptive design, missing data handling, multiple comparisons and simulation techniques.
Experience in organizing regulatory submissions, such as BLA, NDA, sNDA and MAA submissions.
Good working knowledge of ICH, FDA and GCP regulations and guidelines.
Strong leadership skills and team work spirit.
Experience in neurology/cardiovascular therapeutic areas is desirable.
VIEW JOBS10/13/2020 12:00:00 AM2021-01-11T00:00<p>Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. We are combining the precision of gene regulation with the versatility of gene therapies to create breakthrough treatments. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit <a href="http://www.Encoded.com" rel="nofollow noreferrer noopener" class="external">www.Encoded.com</a>. </p><p>This position will be part of the Molecular and Cell-based Assay team responsible for the aspects of developing and executing technical methodologies within Analytical Development Department. This position is a technical laboratory-based position working in a collaborative manner with peers in the QC Department, PD Department and across other technical groups.<br></p><p></p><p></p><p><strong>Responsibilities</strong></p><ul> <li>Develop and optimize molecular assays and/or cell-based assays.</li> <li>Perform AAV vector and cell sample analysis using relevant assays support product development and analytical development.</li> <li>Analyze data and write results summary.</li> <li>Maintain complete and accurate records of work in a timely fashion.</li> <li>Manage workflow and organize storage of samples in freezers and refrigerators.</li> <li>Work on multiple projects to meet departmental and organizational goals.</li> </ul><p><strong>Requirements</strong></p><ul> <li>MSc in a relevant area of specialization (biological sciences, cell biology, molecular biology, virology) and 3 or more years of industry experience.</li> <li>BSc in a relevant area of specialization (biological sciences, cell biology, molecular biology, virology) and 5 or more years of industry experience.</li> <li>Experience in mammalian cell culture and potency assay development (cell biology focus) OR in ddPCR and/or qPCR assay development AND DNA/RNA extraction and quantitative analysis (molecular biology focus).</li> <li>Experience in writing SOPs, developmental and technical reports</li> <li>Highly motivated, flexible and independent, yet successful in a group setting.</li> <li>Strong technical skills along with key competencies including attention to detail, meticulous execution of protocol, excellent organizational and interpersonal capabilities.</li> <li>Familiarity with basic statistical analysis tools and applications.</li> <li>Personnel characteristics of integrity, teamwork and commitment to excellence to fit with</li> </ul><p><strong>Preferred Qualifications:</strong></p><ul><li>Experience working in GLP environment</li></ul><p><strong>Benefits</strong></p><ul> <li>Comprehensive benefits package, including competitive employer premium contributions</li> <li>Meaningful stock option grants</li> <li>PTO, sick time and holiday pay</li> <li>Generous Parental Leave program</li> <li>Pre-tax medical and dependent care programs</li> <li>STD, LTD, Life and AD&D</li> <li>Professional development opportunities</li> <li>Team-building events</li> <li>Fully stocked kitchen</li> <li>Purple Tie dry cleaning service</li> <li>Fitness center</li> </ul><p>Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.</p><p>If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.</p>Encoded TherapeuticsSouth San FranciscoCA
VIEW JOBS10/19/2020 12:00:00 AM2021-01-17T00:00Janssen Research & Development, LLC., a Johnson and Johnson Company is hiring an Associate Director, Biostatistics to support the pulmonary hypertension (PH) Therapeutic Area and to be located in South San Francisco, CA.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolic diseases, and pulmonary hypertension. The Associate Director provides lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence for post-approval studies in the PH therapeutic area. This position takes a leadership role in providing input to develop and implement medical strategies, study protocols, statistical deliverables, and Biostatistics Department's standardizations. Identifies and assists in the implementation of innovative statistical approaches.
Expertise: Has an established track record of problem-solving and troubleshooting including significant regulatory and decision-making support at a program level. Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful support of programs. Is effective in the use of relevant computational tools for study, experiment, interdisciplinary approach and applications for real-world data and real-world evidence, and research objectives. Applies advanced statistical methodology in assigned projects and knowledge of health authority requirements.
Quality and Compliance: Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidance. Takes responsibility for the quality and timeliness of project deliverables, as assessed by stakeholders under medical affairs.
Drug Development: Demonstrates thorough knowledge of pharmaceutical research and development strategies and execution. Is an established leader for providing statistical support to experimental design, methodologies including deriving real-world evidence, analysis planning, analysis execution, result interpretation and communications. Is accountable as a point of contact leader for a specific project or program. Is an established leader for providing input for all biostatistical aspects of the project and/or trial, interacting with regulatory authorities, and communicating statistical functional knowledge to different stakeholders.
Disease Area Knowledge: Demonstrates knowledge across multiple disease areas/targets within pulmonary hypertension.
Innovation: Seen as a leader in an area of technical expertise. Has a track record for suggesting, evaluating and implementing successful alternative or innovative approaches to statistical methods or business processes.
Representation: Represents statistical function in real-world evidence (RWE) activities and clinical trials under PH therapeutic area.
External Engagement: Actively participates as a member of professional organizations and works with PH KOLs to develop new therapies or treatment strategies on PH disease area. Peer reviews or edits professional journal manuscripts.
Mentor: Motors/coaches to statisticians, statistical programmers, and trainees. Shares knowledge within and across functions.
Process: Leads process improvement or standards development initiatives. Provides input into hiring decisions and ongoing evaluation of talent.
Complexity: Successfully works on complex programs in terms of scientific, statistical, health authority, operational, and/or partnership issues. Identifies and implements advanced statistical approaches to handle complex project/program related features.
Collaboration: Builds and manages cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations, consultants, KOLs, researchers, investigators) to achieve results for project specific needs with focus on improving communication, efficiency, and productivity.
Communication: Demonstrates excellent written, oral, and interpersonal communication skills. Demonstrates ability to collaborate and consult with non-statisticians, translating statistical concepts. Bridges scientific and business needs - integrating quantitative sciences and strong disease or functional area knowledge and appropriate market/competitive intelligence.
Programming: Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required.
* Ph.D. in Statistics or related field with minimum 5 years relevant experience in pharmaceutical or biotech industry preferred, or Master's in Statistics or related field with minimum 8 years of relevant experience in pharmaceutical or biotech industry.
* Proficient in SAS required, R programming preferred.
* Excellent written, oral, and interpersonal communication skills.
* Ability to work independently.
* Demonstrated ability to work in interdisciplinary contexts outside statistics.
* Ability to travel up to 10% preferred
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-California-South San Francisco-
Actelion Pharmaceuticals US Inc (6252)
Johnson & JohnsonSouth San FranciscoCA
VIEW JOBS10/19/2020 12:00:00 AM2021-01-17T00:00<p><strong>About IDEAYA Biosciences:</strong></p><p>IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We are applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response.</p><p>IDEAYA recently announced a landmark strategic partnership with GSK in Synthetic Lethality for certain pipeline programs. The GSK partnership is transformative and enables IDEAYA and GSK to collectively build an industry leading platform and pipeline in Synthetic Lethality. For more information, please see <a href="http://www.ideayabio.com" rel="nofollow noreferrer noopener" class="external">www.ideayabio.com</a>.</p><p><strong>Position Summary:</strong></p><p>IDEAYA is seeking a talented and highly motivated Clinical Trial Manager/Senior Clinical Trial Manager of Clinical Operations with a passion for new cancer therapy development. This role will be responsible for providing leadership to Study Execution Team (SET) and oversight of clinical trials for IDEAYA’s early stage clinical programs.</p><p>As a Clinical Trial Manager/Senior Clinical Trial Manager, you will work directly with Medical Monitor and other cross-functional representatives including Clinical Data Management, Regulatory, Pharmacology and Translational Science and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables. You will apply your technical skills, learn new skills and play a key role in clinical trial planning and execution. As a member of our dynamic group, you will help to grow IDEAYA’s pipeline.</p><p><br></p><p><strong>What you'll do:</strong></p><ul> <li>Lead SET to ensure trials are initiated efficiently and completed on time, within budget and in compliance with Standard Operation Procedures (SOPs), FDA regulations and ICH/GCP guidelines</li> <li>In collaboration with SET, develop and facilitate Request for Proposals, review proposals and contribute to selection of Contract Research Organizations (CROs) and other clinical vendors for the right strategic fit</li> <li>Be accountable for the management of CRO and other clinical vendors to ensure that project and Corporate goals are achieved on time and within budget</li> <li>Write or contribute to preparation of clinical documents (e.g., protocols, informed consent forms, case report forms, study reference manuals, study plans)</li> </ul><ul><li>Partner with Clinical Development and CRO colleagues for clinical trial planning</li></ul><ul><li>Lead study activities including investigator selection, study start-up, recruitment, data collection and review, and monitoring oversight</li></ul><ul><li>Participate in implementation and oversight of clinical systems including but not limited to CTMS, TMF, EDC and IRT</li></ul><ul><li>Provide quality oversight to ensure inspection readiness</li></ul><ul> <li>Review and track key study metrics and progress reports; identify barriers to timely and successful trial execution and propose creative solutions</li> <li>Establish and maintain strong relationships with internal cross-functional teams, CROS and vendors, and clinical research site personnel for successful execution of clinical trials</li> </ul><ul><li>Train investigators and site staff, vendor staff and team members on study protocol and trial conduct processes</li></ul><ul> <li>Develop and revise SOPs and work instructions, and participate in building of department infrastructure as needed</li> </ul><p><strong>Requirements</strong></p><p><strong>AKA what you will bring:</strong></p><ul> <li>Bachelors in life sciences or related discipline with 4-6 years of experience in clinical and drug development</li> <li>Clinical study management and vendor management experience in oncology</li> <li>Early phase oncology trial management experience preferred</li> <li>Excellent knowledge of FDA and ICH/GCP regulations and guidelines</li> <li>Self-motivated and takes pride in your work</li> <li>Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships</li> <li>Detailed oriented and creative thinker with a passion for process optimization</li> <li>Excellent organizational and communication skills</li> <li>Analyze and triage problems, prioritize accordingly, and propose solutions</li> <li>Ability to travel as required (approximately 20%)</li> </ul><p><strong>Benefits</strong></p><p>When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward.</p><p>IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets</p>Ideaya BiosciencesSouth San FranciscoCA